Topical anti-inflammatory treatments for eczema: network meta-analysis
- PMID: 39105474
- PMCID: PMC11301992
- DOI: 10.1002/14651858.CD015064.pub2
Topical anti-inflammatory treatments for eczema: network meta-analysis
Abstract
Background: Eczema (atopic dermatitis) is the most burdensome skin condition worldwide and cannot currently be prevented or cured. Topical anti-inflammatory treatments are used to control eczema symptoms, but there is uncertainty about the relative effectiveness and safety of different topical anti-inflammatory treatments.
Objectives: To compare and rank the efficacy and safety of topical anti-inflammatory treatments for people with eczema using a network meta-analysis.
Search methods: We searched the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and trial registries on 29 June 2023, and checked the reference lists of included studies.
Selection criteria: We included within-participant or between-participant randomised controlled trials (RCTs) in people of any age with eczema of any severity, but excluded trials in clinically infected eczema, seborrhoeic eczema, contact eczema, or hand eczema. We included topical anti-inflammatory treatments used for at least one week, compared with another anti-inflammatory treatment, no treatment, or vehicle/placebo. Vehicle is a 'carrier system' for an active pharmaceutical substance, which may also be used on its own as an emollient for dry skin. We excluded trials of topical antibiotics used alone, complementary therapies, emollients used alone, phototherapy, wet wraps, and systemic treatments.
Data collection and analysis: We used standard Cochrane methods. Primary outcomes were patient-reported eczema symptoms, clinician-reported eczema signs and investigator global assessment. Secondary outcomes were health-related quality of life, long-term control of eczema, withdrawal from treatment/study, and local adverse effects (application-site reactions, pigmentation changes and skin thinning/atrophy were identified as important concerns through patient and public involvement). We used CINeMA to quantify our confidence in the evidence for each outcome.
Main results: We included 291 studies involving 45,846 participants with the full spectrum of eczema severity, mainly conducted in high-income countries in secondary care settings. Most studies included adults, with only 31 studies limited to children aged < 12 years. Studies usually included male and female participants, multiple ethnic groups but predominantly white populations. Most studies were industry-funded (68%) or did not report their funding sources/details. Treatment duration and trial participation were a median of 21 and 28 days (ranging from 7 days to 5 years), respectively. Interventions used were topical corticosteroids (TCS) (172), topical calcineurin inhibitors (TCI) (134), phosphodiesterase-4 (PDE-4) inhibitors (55), janus kinase (JAK) inhibitors (30), aryl hydrocarbon receptor activators (10), or other topical agents (21). Comparators included vehicle (170) or other anti-inflammatory treatments. The risk of bias was high in 242 of the 272 (89.0%) trials contributing to data analyses, most commonly due to concerns about selective reporting. Network meta-analysis (NMA) was only possible for short-term outcomes. Patient-reported symptoms NMA of 40 trials (6482 participants) reporting patient-reported symptoms as a binary outcome ranked tacrolimus 0.1% (OR 6.27, 95% CI 1.19 to 32.98), potent TCS (OR 5.99, 95% CI 2.83 to 12.69), and ruxolitinib 1.5% (OR 5.64, 95% CI 1.26 to 25.25) as the most effective, all with low confidence. Mild TCS, roflumilast 0.15%, and crisaborole 2% were the least effective. Class-level sensitivity analysis found potent/very potent TCS had similar effectiveness to potent TCI and was more effective than mild TCI and PDE-4 inhibitors. NMA of 29 trials (3839 participants) reporting patient-reported symptoms as a continuous outcome ranked very potent TCS (SMD -1.99, 95% CI -3.25 to -0.73; low confidence) and tacrolimus 0.03% (SMD -1.57, 95% CI -2.42 to -0.72; moderate confidence) the highest. Direct information for tacrolimus 0.03% was based on one trial of 60 participants at high risk of bias. Roflumilast 0.15%, delgocitinib 0.25% or 0.5%, and tapinarof 1% were the least effective. Class-level sensitivity analysis found potent/very potent TCS had similar effectiveness to potent TCI and JAK inhibitors and mild/moderate TCS was less effective than mild TCI. A further 50 trials (9636 participants) reported patient-reported symptoms as a continuous outcome but could not be included in NMA. Clinician-reported signs NMA of 32 trials (4121 participants) reported clinician signs as a binary outcome and ranked potent TCS (OR 8.15, 95% CI 4.99, 13.57), tacrolimus 0.1% (OR 8.06, 95% CI 3.30, 19.67), ruxolitinib 1.5% (OR 7.72, 95% CI 4.92, 12.10), and delgocitinib 0.5% (OR 7.61, 95% CI 3.72, 15.58) as most effective, all with moderate confidence. Mild TCS, roflumilast 0.15%, crisaborole 2%, and tapinarof 1% were the least effective. Class-level sensitivity analysis found potent/very potent TCS more effective than potent TCI, mild TCI, JAK inhibitors, PDE-4 inhibitors; and mild TCS and PDE-4 inhibitors had similar effectiveness. NMA of 49 trials (5261 participants) reported clinician signs as a continuous outcome and ranked tacrolimus 0.03% (SMD -2.69, 95% CI -3.36, -2.02) and very potent TCS (SMD -1.87, 95% CI -2.69, -1.05) as most effective, both with moderate confidence; roflumilast 0.15%, difamilast 0.3% and tapinarof 1% were ranked as least effective. Direct information for tacrolimus 0.03% was based on one trial in 60 participants with a high risk of bias. For some sensitivity analyses, potent TCS, tacrolimus 0.1%, ruxolitinib 1.5%, delgocitinib 0.5% and delgocitinib 0.25% became some of the most effective treatments. Class-level analysis found potent/very potent TCS had similar effectiveness to potent TCI and JAK inhibitors, and moderate/mild TCS was more effective than mild TCI. A further 100 trials (22,814 participants) reported clinician signs as a continuous outcome but could not be included in NMA. Investigator Global Assessment NMA of 140 trials (23,383 participants) reported IGA as a binary outcome and ranked ruxolitinib 1.5% (OR 9.34, 95% CI 4.8, 18.18), delgocitinib 0.5% (OR 10.08, 95% CI 2.65, 38.37), delgocitinib 0.25% (OR 6.87, 95% CI 1.79, 26.33), very potent TCS (OR 8.34, 95% CI 4.73, 14.67), potent TCS (OR 5.00, 95% CI 3.80, 6.58), and tacrolimus 0.1% (OR 5.06, 95% CI 3.59, 7.13) as most effective, all with moderate confidence. Mild TCS, crisaborole 2%, pimecrolimus 1%, roflumilast 0.15%, difamilast 0.3% and 1%, and tacrolimus 0.03% were the least effective. In a sensitivity analysis of low risk of bias information (12 trials, 1639 participants), potent TCS, delgocitinib 0.5% and delgocitinib 0.25% were most effective, and pimecrolimus 1%, roflumilast 0.15%, difamilast 1% and difamilast 0.3% least effective. Class-level sensitivity analysis found potent/very potent TCS had similar effectiveness to potent TCI and JAK inhibitors and were more effective than PDE-4 inhibitors; mild/moderate TCS were less effective than potent TCI and had similar effectiveness to mild TCI. Longer-term outcomes over 6 to 12 months showed a possible increase in effectiveness for pimecrolimus 1% versus vehicle (4 trials, 2218 participants) in a pairwise meta-analysis, and greater treatment success with mild/moderate TCS than pimecrolimus 1% (based on 1 trial of 2045 participants). Local adverse effects NMA of 83 trials (18,992 participants, 2424 events) reporting application-site reactions ranked tacrolimus 0.1% (OR 2.2, 95% CI 1.53, 3.17; moderate confidence), crisaborole 2% (OR 2.12, 95% CI 1.18, 3.81; high confidence), tacrolimus 0.03% (OR 1.51, 95%CI 1.10, 2.09; low confidence), and pimecrolimus 1% (OR 1.44, 95% CI 1.01, 2.04; low confidence) as most likely to cause site reactions. Very potent, potent, moderate, and mild TCS were least likely to cause site reactions. NMA of eight trials (1786 participants, 3 events) reporting pigmentation changes found no evidence for increased pigmentation changes with TCS and crisaborole 2%, with low confidence for mild, moderate or potent TCS and moderate confidence for crisaborole 2%. NMA of 25 trials (3691 participants, 36 events) reporting skin thinning found no evidence for increased skin thinning with short-term (median 3 weeks, range 1-16 weeks) use of mild TCS (OR 0.72, 95% CI 0.12, 4.31), moderate TCS (OR 0.91, 95% CI 0.16, 5.33), potent TCS (OR 0.96, 95% CI 0.21, 4.43) or very potent TCS (OR 0.88, 95% CI 0.31, 2.49), all with low confidence. Longer-term outcomes over 6 to 60 months showed increased skin thinning with mild to potent TCS versus TCI (3 trials, 4069 participants, 6 events with TCS).
Authors' conclusions: Potent TCS, JAK inhibitors and tacrolimus 0.1% were consistently ranked as amongst the most effective topical anti-inflammatory treatments for eczema and PDE-4 inhibitors as amongst the least effective. Mild TCS and tapinarof 1% were ranked amongst the least effective treatments in three of five efficacy networks. TCI and crisaborole 2% were ranked most likely to cause local application-site reactions and TCS least likely. We found no evidence for increased skin thinning with short-term TCS but an increase with longer-term TCS.
Copyright © 2024 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.
Conflict of interest statement
EA, RB, HW, RP, and AD have had editorial roles at Cochrane, but were not involved in the editorial process or decision‐making for this review.
Figures
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References
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Dou 2006a {published data only}
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- Dou X, Liu LL, Xie ZQ, Chen LJ, Li L, Feng SY, et al. The impact of tacrolimus ointment on health-related quality of life of Chinese adult and pediatric patients with atopic dermatitis [Chinese]. Journal of Clinical Dermatology 2006;35(1):50-2.
Dou 2006b {published data only}
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- Dou X, Liu LL, Xie ZQ, Chen LJ, Li L, Feng SY, et al. The impact of tacrolimus ointment on health-related quality of life of Chinese adult and pediatric patients with atopic dermatitis [Chinese]. Journal of Clinical Dermatology 2006;35(1):50-2.
Draelos 2005 {published data only}
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- Draelos Z, Nayak A, Pariser D, Shupack JL, Chon K, Abrams B, et al. Pharmacokinetics of topical calcineurin inhibitors in adult atopic dermatitis: a randomized, investigator-blind comparison. Journal of the American Academy of Dermatology 2005;53(4):602-9. - PubMed
Duke 1983 {published data only}
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- Duke EE, Maddin S, Aggerwal A. Alclometasone dipropionate in atopic dermatitis: a clinical study. Current Therapeutic Research, Clinical and Experimental 1983;33(5):769-74.
Eichenfield 2002a {published data only}
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- Barbier N, Paul C, Luger T, Allen R, De Prost Y, Papp K, et al. Validation of the eczema area and severity index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. British Journal of Dermatology 2004;150(1):96‐102. - PubMed
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- Boguniewicz M, Eichenfield L, Honig P, Langley R, Lucky A, Paller A, et al. Pimecrolimus (ElidelA, SDZ ASM 981) cream 1% is safe in the long term management of atopic eczema. Journal of the European Academy of Dermatology and Venereology : JEADV 2001;15(S2):110.
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- Boguniewicz M, Eichenfield L, Ling M, Cherill R. Pimecrolimus (SDZ ASM 981) cream 1% provides significant and rapid relief of pruritus in pediatric patients with moderate to severe atopic dermatitis. Journal of Investigative Dermatology 2002;119(1):348.
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- Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Cherill R, Marshall K, et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. Journal of the American Academy of Dermatology 2002;46(4):495-504. - PubMed
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- Eichenfield LF, Lucky AW, Langley RG, Lynde C, Kaufmann R, Todd G, et al. Use of pimecrolimus cream 1% (Elidel) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome. International Journal of Dermatology 2005;44(1):70-5. - PubMed
Eichenfield 2002b {published data only}
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- Eichenfield LF, Lucky AW, Boguniewicz M, Langley RG, Cherill R, Marshall K, et al. Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents. Journal of the American Academy of Dermatology 2002;46(4):495-504. - PubMed
Eichenfield 2006a {published data only}
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- Eichenfield LF, Miller BH, Cutivate Lotion Study Group. Two randomized, double-blind, placebo-controlled studies of fluticasone propionate lotion 0.05% for the treatment of atopic dermatitis in subjects from 3 months of age. Journal of the American Academy of Dermatology 2006;54(4):715-7. - PubMed
Eichenfield 2006b {published data only}
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- Eichenfield LF, Miller BH, Cutivate Lotion Study Group. Two randomized, double-blind, placebo-controlled studies of fluticasone propionate lotion 0.05% for the treatment of atopic dermatitis in subjects from 3 months of age. Journal of the American Academy of Dermatology 2006;54(4):715-7. - PubMed
El‐Hefnawi 1978 {published data only}
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- El-Hefnawi H, El-Shiemy S, Paris R, Tadros SS. Double-blind paired comparison clinical trial of halcinonide and hydrocortisone. Cutis; Cutaneous Medicine for the Practitioner 1978;22(1):97-9. - PubMed
Emer 2011 {published data only}
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- Emer JJ, Frankel A, Sohn A, Lebwohl M. A bilateral comparison study of pimecrolimus cream 1% and a topical medical device cream in the treatment of patients with atopic dermatitis. Journal of Drugs in Dermatology 2011;10(7):735-43. - PubMed
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- NCT01177566. Pimecrolimus cream 1% (Elidel®) and medicated device cream (EletoneTM) in the treatment and maintenance of atopic dermatitis. clinicaltrials.gov/show/NCT01177566 (first received 9 August 2010).
EUCTR2004‐001036‐23‐IT {published data only}
-
- EUCTR2004-001036-23-IT. A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of Elidel Cream 1% in mild to moderate head and neck atopic dermatitis of patients intolerant of topical corticosteroids. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2004-001036-23-IT (first received 29 December 2004).
EUCTR2004‐002688‐25‐GB {published data only}
-
- EUCTR2004-002688-25-GB. A 4-week, randomized, multicenter, parallel-group, placebo-controlled study to investigate the effect of Elidel (pimecrolimus) cream 1% on the Quality of Life (QoL) of patients with moderate facial Atopic Eczema (AE), in whom previous treatment, including appropriate use of topical corticosteroids (TCS), has been unsatisfactory. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2004-002688-25-GB (first received 27 June 2005).
EUCTR2005‐001650‐25‐DE {published data only}
-
- EUCTR2005-001650-25-DE. A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the efficacy and safety of Elidel® Cream 1% in mild to moderate facial atopic dermatitis of patients (2 to 11 years of age, inclusive) intolerant of, or dependent on, topical corticosteroids. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2005-001650-25-DE (first received 12 August 2005).
EUCTR2009‐012028‐98‐DE {published data only}
-
- EUCTR2009-012028-98-DE. A placebo-controlled, multicentre, double-blinded, intra-individual comparison to gain evidence of the safety, tolerability and efficacy of prednicarbat cream and ointment in patients with active atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2009-012028-98-DE (first received 4 May 2009).
EUCTR2009‐013792‐22‐FI {published data only}
-
- EUCTR2009-013792-22-FI. A phase 2, proof of concept and dose finding study, investigating treatment efficacy of LEO 29102 cream (2.5 mg/g, 1.0 mg/g, 0.3 mg/g, 0.1 mg/g, 0.03 mg/g), LEO 29102 cream vehicle, and Elidel (Pimecrolimus) cream 10 mg/g, after cutaneous administration twice daily for 4 weeks. An international, multi-centre, prospective, randomised, double-blind, 7 arm, vehicle-controlled, parallel group study [LEO 29102 cream in the treatment of atopic dermatitis]. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2009-013792-22-FI (first received 8 October 2009).
EUCTR2010‐024279‐14‐CZ {published data only}
-
- EUCTR2010-024279-14-CZ. Double-blind, randomized, vehicle-controlled, multicenter, multinational, parallel-group study of the efficacy and safety of mapracorat ointment in concentrations of 0.01%, 0.03% and 0.1% over max. 4 weeks in subjects with Atopic Dermatitis (AD) - efficacy and safety of different concentrations of mapracorat in AD. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2010-024279-14-CZ (first received 4 February 2011).
EUCTR2011‐001175‐38‐DE {published data only}
-
- EUCTR2011-001175-38-DE. Comparison of defined skin parameters in two comparable lesional skin areas after topical treatment with Soventol HydroCort 0.5 % Cremogel or placebo. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2011-001175-38-DE (first received 4 November 2011).
EUCTR2015‐004899‐30‐Outside‐EU/EEA {published data only}
-
- EUCTR2015-004899-30-Outside-EU/EEA. Study into the safety and efficacy of eczema cream clobetasone butyrate. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2015-004899-30-Outside-EU/EEA (first received 21 December 2016).
Fadrhoncova 1982 {published data only}
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- Fadrhoncova A. Comparative clinical trial with 1% hydrocortisone and 0.1% hydrocortisone butyrate cream in non-infected eczema. Cesko-Slovenska Dermatologie 1982;57(6):309-15.
Fattah 1976 {published data only}
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- Fattah AA, El-Shiemy S, Faris R, Tadros SS. A comparative clinical evaluation of a new topical steroid 'halcinonide' and hydrocortisone in steroid-responsive dermatoses. Journal of International Medical Research 1976;4(4):228-31. - PubMed
Fisher 1979 {published data only}
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- Fisher M, Kelly AP. Multicenter trial of fluocinonide in an emollient cream base. International Journal of Dermatology 1979;18(8):660-4. - PubMed
Fowler 2007 {published data only}
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- Fowler J, Johnson A, Chen M, Abrams K. Improvement in pruritus in children with atopic dermatitis using pimecrolimus cream 1%. Cutis; Cutaneous Medicine for the Practitioner 2007;79(1):65-72. - PubMed
Frankel 2011 {published data only}
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- Frankel A, Sohn A, Emer J, Lebwohl M. Bilateral comparison study of pimecrolimus cream 1% and a ceramide-hyaluronic acid based emollient foam in the treatment of patients with atopic dermatitis. Journal of the American Academy of Dermatology 2011;64(2 Suppl 1):AB59. - PubMed
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- Frankel A, Sohn A, Patel RV, Lebwohl M. Bilateral comparison study of pimecrolimus cream 1% and a ceramide-hyaluronic acid emollient foam in the treatment of patients with atopic dermatitis. Journal of Drugs in Dermatology 2011;10(6):666-72. - PubMed
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- NCT01202149. Bilateral comparison study of Elidel 1% and hylatopic plus emollient foam for the treatment of subjects with atopic dermatitis. clinicaltrials.gov/show/NCT01202149 (first received 15 September 2010).
Freeman 2006 {published data only}
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- Freeman S, Day R, Williams K, Liauw W. A new treatment for atopic dermatitis: a randomized double-blind placebo-controlled study. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB3.
Fujita 2021 {published data only}
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- Fujita K, Yagi M, Moriwaki S, Yoshida M, Graham D. A phase 2b, randomized, double-blind, multicenter, vehicle-controlled study to assess the efficacy and safety of two crisaborole regimens in Japanese patients aged 2 years and older with mild-to-moderate atopic dermatitis. Journal of Dermatology 2021;48(11):1640‐51. - PMC - PubMed
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- NCT03954158. Study to assess efficacy and safety of two regimens of crisaborole ointment 2% in Japanese participants aged ≥ 2 years with mild to moderate atopic dermatitis. clinicaltrials.gov/show/NCT03954158 (first received 17 May 2019).
Furue 2014 {published data only}
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- Furue M, Kitahara Y, Akama H, Hojo S, Hayashi N, Nakagawa H. Safety and efficacy of topical E6005, a phosphodiesterase 4 inhibitor, in Japanese adult patients with atopic dermatitis: results of a randomized, vehicle-controlled, multicenter clinical trial. Journal of Dermatology 2014;41(7):577‐85. - PubMed
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- Kitahara Y, Hojo S, Nomoto M, Onozuka D, Furue M, Hagihara A. Pharmacokinetic disposition of topical phosphodiesterase-4 inhibitor E6005 in patients with atopic dermatitis. Journal of Dermatological Treatment 2019;30(5):466‐70. - PubMed
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- NCT01461941. A phase 2 study of E6005 in patients with atopic dermatitis. clinicaltrials.gov/show/NCT01461941 (first received 28 October 2011).
Gehring 1996 {published data only}
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- Gehring W, Gloor M. Treatment of the atopic dermatitis with a water-in-oil emulsion with or without the addition of hydrocortisone - results of a controlled double-blind randomized study using clinical evaluation and bioengineering methods. Zeitschrift fur Hautkrankheiten 1996;71(7):554-60.
Gelmetti 1978 {published data only}
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- Gelmetti C. Double blind comparison of diflucortolone valerate and betamethasone valerate. Giornale Italiano di Dermatologia/Minerva Dermatologica 1978;113(5):307-9.
Gentry 1973 {published data only}
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- Gentry WC, Rosenberg EW, Goltz RW. A clinical evaluation of 0.05% desonide cream. A new nonfluorinated topical corticosteroid. Archives of Dermatology 1973;107(6):870-1. - PubMed
Gether 2023 {published data only}
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- Gether L, Storgaard H, Kezic S, Jakasa I, Hartmann B, Skov-Jeppesen K, et al. Effects of topical corticosteroid versus tacrolimus on insulin sensitivity and bone homeostasis in adults with atopic dermatitis: a randomized controlled study. Allergy 2023;78:1964-79. - PubMed
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- NCT04114097. The effects of topical corticosteroid use on insulin sensitivity and bone turnover. clinicaltrials.gov/show/NCT04114097 (first received 3 October 2019).
Ghatikar 1974 {published data only}
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- Ghatikar KN. A multicentric trial of a new steroid, betamethasone benzoate, in common dermatological disorders. Current Therapeutic Research, Clinical and Experimental 1974;16(6):585-92. - PubMed
Giannetti 1981 {published data only}
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- Giannetti A, Laria G, Seidenari S. Hydrocortisone-17-butyrate (0.1 percent) versus hydrocortisone acetate (1 percent) in atopic dermatitis. Controlled double-blind study of 20 children. Minerva Pediatrica 1981;33(12):597-600. - PubMed
Goh 1999 {published data only}
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- Goh CL, Lim JT, Leow YH, Ang CB, Kohar YM. The therapeutic efficacy of mometasone furoate cream 0.1% applied once daily vs clobetasol propionate cream 0.05% applied twice daily in chronic eczema. Singapore Medical Journal 1999;40(5):341-4. - PubMed
Gooderham 2021 {published data only}
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- Gooderham M, Kircik L, Zirwas M, Lee M, Kempers S, Draelos Z, El al. The safety and efficacy of roflumilast cream 0.15% and 0.05% in patients with atopic dermatitis: randomized, double-blind, phase 2 proof of concept study. Journal of Clinical and Aesthetic Dermatology 2021;14:S15-S16. - PubMed
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- Gooderham M, Kircik L, Zirwas M, Lee M, Kempers SE, Draelos Z, et al. The safety and efficacy of roflumilast cream 0.15% and 0.05% in atopic dermatitis: phase II proof-of-concept study. Journal of Clinical and Aesthetic Dermatology 2021;14(5S1):S15‐S16.
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- Gooderham MJ, Kircik LH, Zirwas M, Lee M, Kempers SE, Draelos ZD, et al. The safety and efficacy of roflumilast cream 0.15% and 0.05% in atopic dermatitis: phase II proof-of-concept study. British Journal of Dermatology 2021;184(3):e69.
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- NCT03916081. Safety and efficacy of ARQ-151 cream in adolescents and adults with atopic dermatitis. clinicaltrials.gov/show/NCT03916081 (first received 16 April 2019).
Gower 2022 {published data only}
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- Eichenfield LF, Gower RG, Xu JH, Alam MS, Su JC, Myers DE, et al. Once-daily crisaborole ointment, 2%, as a long-term maintenance treatment in patients aged >= 3 months with mild-to-moderate atopic dermatitis: a 52-week clinical study. American Journal of Clinical Dermatology 2023;24:623-35. - PMC - PubMed
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- NCT04040192. A study to evaluate long-term maintenance treatment with once daily crisaborole ointment 2% in pediatric and adult participants with mild-to-moderate atopic dermatitis. clinicaltrials.gov/show/NCT04040192 (first received 31 July 2019).
Gradman 2007 {published data only}
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- Gradman J, Wolthers OD. Short-term growth in children with eczema during treatment with topical mometasone furoate and tacrolimus. Acta Paediatrica 2007;96(8):1233-7. - PubMed
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- NCT00236106. Short term growth in children with atopic dermatitis. clinicaltrials.gov/show/NCT00236106 (first received 12 October 2005).
Griffiths 2002 {published data only}
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- Griffiths CE, Van Leent EJ, Gilbert M, Traulsen J. Randomised comparison of the type 4 phosphodiesterase inhibitor cipamfylline cream, cream vehicle and hydrocortisone 17-butyrate cream in atopic dermatitis. British Journal of Dermatology 2001;145(Suppl 59):46-7. - PubMed
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- Griffiths CE, Van Leent EJ, Gilbert M, Traulsen J, Cipamyflline Study Group. Randomized comparison of the type 4 phosphodiesterase inhibitor cipamfylline cream, cream vehicle and hydrocortisone 17-butyrate cream for the treatment of atopic dermatitis. British Journal of Dermatology 2002;147(2):299-307. - PubMed
Guttman‐Yassky 2017a {published data only}
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- Guttman-Yassky E, Suarez-Farinas M, Ungar B, Oliva M, Suprun M, Todd D, et al. A model to evaluate intra-patient differential effects of topical agents in atopic dermatitis. Journal of Investigative Dermatology (Conference: 2016 Annual Meeting of the Society for Investigative Dermatology) 2016;136:S96.
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- Guttman-Yassky E, Ungar B, Malik K, Dickstein D, Suprun M, Estrada YD, et al. Molecular signatures order the potency of topically applied anti-inflammatory drugs in patients with atopic dermatitis. Journal of Allergy and Clinical Immunology 2017;140(4):1032-42. - PubMed
Guttman‐Yassky 2019 {published data only}
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- Guttman-Yassky E, Pavel AB, Durham T, Maeda-Chubachi T. Topical nitric oxide releasing therapy with 2% SB414 cream downregulated major gene expressions in patients with atopic dermatitis. Journal of Investigative Dermatology 2019;139(5 Suppl):S101.
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- Maeda-Chubachi T, Durham T, Schleicher S, Rich P, Guttman-Yassky E. A topical nitric oxide-releasing cream SB414: results of a phase 1b double-blind, randomized, vehicle-controlled study in patients with mild-to-moderate atopic dermatitis. Experimental Dermatology 2018;27(S2):14.
Hamza 2018 {published data only}
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- Hamza M, Lebwohl M, Thaci D, Weissbach M, Coughlan D, Guttman-Yassky E, et al. Topical DS107 for the treatment of mild-to-moderate atopic dermatitis: results from ADVANTAGE, an 8 week phase 2b randomized, double-blind, vehicle-controlled study. Experimental Dermatology 2018;27:37‐8.
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- NCT02925793. Safety and efficacy study of topically applied DS107 cream in mild to moderate atopic dermatitis patients. clinicaltrials.gov/show/NCT02925793 (first received 6 October 2016).
Handa 1985 {published data only}
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- Handa F, Puri KP. A randomized double blind study of ointment containing diflucortolone valerate and hydrocortisone acetate. Indian Journal of Dermatology, Venereology and Leprology 1985;51(5):261-2. - PubMed
Handa 2022 {published data only}
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- Handa S, Chandrasegaran A, Kanwar AJ, Mahajan R. Comparing the effectiveness of topical fluticasone 0.05% cream versus topical tacrolimus 0.1% ointment in pediatric atopic dermatitis: a randomized controlled trial. Indian Journal of Paediatric Dermatology 2022;23(2):111-5.
Hanifin 2001a {published data only}
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- Beltrani VS. Tacrolimus ointment: advancing the treatment of atopic dermatitis. Current Allergy and Asthma Reports 2001;1(4):307-8. - PubMed
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- Drake L, Prendergast M, Maher R, Breneman D, Korman N, Satoi Y, et al. The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis. Journal of the American Academy of Dermatology 2001;44(Suppl 1):S65-72. - PubMed
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- Fleischer AB Jr, Ling M, Eichenfield L, Satoi Y, Jaracz E, Rico MJ, et al. Tacrolimus ointment for the treatment of atopic dermatitis is not associated with an increase in cutaneous infections. Journal of the American Academy of Dermatology 2002;47(4):562-70. - PubMed
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- Hanifin JM, Ling MR, Langley R, Breneman D, Rafal E. Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part I, efficacy. Journal of the American Academy of Dermatology 2001;44(Suppl 1):S28-38. - PubMed
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- Kang S, Paller A, Soter N, Satoi Y, Rico MJ, Hanifin JM. Safe treatment of head/neck AD with tacrolimus ointment. Journal of Dermatological Treatment 2003;14(2):86-94. - PubMed
Hanifin 2001b {published data only}
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- Paller A, Eichenfield LF, Leung DY, Stewart D, Appell M. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. Journal of the American Academy of Dermatology 2001;Vol. 44(Suppl 1):S47-57. - PubMed
Hanifin 2001c {published data only}
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- Paller A, Eichenfield LF, Leung DY, Stewart D, Appell M. A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients. Journal of the American Academy of Dermatology 2001;Vol. 44(Suppl 1):s47-s57. - PubMed
Hanifin 2010 {published data only}
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- Hanifin JM, Boguniewicz M, Eichenfield LF, Schneider LC, Paller AS, Preston JA, et al. A long-term study of safety and allergic comorbidity development in a randomized trial of pimecrolimus cream in infants with atopic dermatitis. Journal of Investigative Dermatology 2010;130(Suppl 1):S55.
Hanifin 2016 {published data only}
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- EUCTR2013-003899-12-PL. Protocol 271-12-205: a Phase 2 multi-center, randomized, double-blind, vehicle-controlled, three-arm, parallel group study to assess the safety, tolerability, and efficacy of topical OPA-15406 ointment, in subjects with mild/moderate atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2013-003899-12-PL (first received 19 August 2014).
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- Hanifin J, Shideler S, Eichenfield L, Secci A, Smith A, Kornyeyeva E. To report efficacy results from an 8-week phase 2 study treating adolescents and adults with mild to moderate atopic dermatitis treated with 0.3% and 1% OPA-15406 ointment. Acta Dermato-Venereologica 2015;95(7):886.
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- Hanifin JM, Ellis CN, Frieden IJ, Folster-Holst R, Stein Gold LF, Secci A, et al. OPA-15406, a novel, topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (AD): a phase-II randomized, double-blind, placebo-controlled study. Journal of the American Academy of Dermatology 2016;75(2):297-305. - PubMed
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- NCT02068352. A study to evaluate the effectiveness and safety of a topical OPA-15406 ointment to treat subjects with atopic dermatitis. clinicaltrials.gov/show/NCT02068352 (first received 21 February 2014).
Harder 1983 {published data only}
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- Harder F, Rufli T. Therapy of eczema. Once daily use of diflorasone diacetate in comparison to thrice daily use of betamethasone-17-valerate. Schweizerische Rundschau fur Medizin Praxis 1983;72(39):1240-2. - PubMed
Haribhakti 1982 {published data only}
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- Haribhakti BP. Comparative study of clobetasone butyrate cream (Eumovate) and hydrocortisone cream in children with eczema. Indian Journal of Dermatology, Venereology and Leprology 1982;48(6):344-7. - PubMed
Hebert 2006 {published data only}
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- Hebert AA, Koo J, Fowler J, Berman B, Rosenberg C, Levitt J. Desoximetasone 0.25% and tacrolimus 0.1% ointments versus tacrolimus alone in the treatment of atopic dermatitis. Cutis; Cutaneous Medicine for the Practitioner 2006;78(5):357-63. - PubMed
Hebert 2007a {published data only}
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- Hebert AA, Cook-Bolden FE, Basu S, Calvarese B, Trancik RJ, Desonide Hydrogel Study Group. Safety and efficacy of desonide hydrogel 0.05% in pediatric subjects with atopic dermatitis. Journal of Drugs in Dermatology 2007;6(2):175-81. - PubMed
Hebert 2007b {published data only}
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- Hebert AA, Cook-Bolden FE, Basu S, Calvarese B, Trancik RJ, Desonide Hydrogel Study Group. Safety and efficacy of desonide hydrogel 0.05% in pediatric subjects with atopic dermatitis. Journal of Drugs in Dermatology 2007;6(2):175-81. - PubMed
Hebert 2008a {published data only}
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- Friedlander SF, Loss R, Schlessinger J, Potts A. A phase 3 double-blind, randomized, vehicle-controlled study of desonide foam in pediatric and adolescent patients with mild to moderate atopic dermatitis. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB84.
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- Hebert AA. Desonide foam 0.05%: safety in children as young as 3 months. Journal of the American Academy of Dermatology 2008;59(2):334‐40. - PubMed
Hebert 2008b {published data only}
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- Hebert AA. Desonide foam 0.05%: safety in children as young as 3 months. Journal of the American Academy of Dermatology 2008;59(2):334‐40. - PubMed
Hebert 2008c {published data only}
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- Hebert AA. Desonide foam 0.05%: safety in children as young as 3 months. Journal of the American Academy of Dermatology 2008;59(2):334‐40. - PubMed
Ho 2003 {published data only}
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- Eichenfield LF, Lucky AW, Langley RG, Lynde C, Kaufmann R, Todd G, et al. Use of pimecrolimus cream 1% (Elidel) in the treatment of atopic dermatitis in infants and children: the effects of ethnic origin and baseline disease severity on treatment outcome. International Journal of Dermatology 2005;44(1):70-5. - PubMed
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- Ho V, Halbert A, Takaoka R, Kauffman R, Todd G, Vanaclocha F, et al. Pimecrolimus (Elidel®, SDZ ASM 981) cream 1% is effective and safe in infants aged 3-23 months with atopic eczema. Journal of the European Academy of Dermatology and Venereology : JEADV 2001;15(Suppl s2):110.
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- Ho V, Hedgecock S, Bush C, Marshall K, Thurston M, Graeber M. SDZ ASM 981 cream 1% is efficacious and safe in infants aged 3-23 months with atopic dermatitis. Journal of Investigative Dermatology 2001;117(2):532.
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- Ho VC, Gupta A, Kaufmann R, Todd G, Vanaclocha F, Takaoka R, et al. Safety and efficacy of nonsteroid pimecrolimus cream 1% in the treatment of atopic dermatitis in infants. Journal of Pediatrics 2003;142(2):155-62. - PubMed
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- Whalley D, Huels J, McKenna SP, Van Assche D. The benefit of pimecrolimus (Elidel, SDZ ASM 981) on parents' quality of life in the treatment of pediatric atopic dermatitis. Pediatrics 2002;110(6):1133-6. - PubMed
Hoeger 2009 {published data only}
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- Hoeger PH, Lee KH, Jautova J, Wohlrab J, Guettner A, Mizutani G, et al. The treatment of facial atopic dermatitis in children who are intolerant of, or dependent on, topical corticosteroids: a randomized, controlled clinical trial. British Journal of Dermatology 2009;160(2):415-22. - PubMed
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- NCT00130364. Efficacy and safety of pimecrolimus cream 1% in patients (2 to 11 years old) with mild to moderate facial atopic dermatitis. clinicaltrials.gov/show/NCT00130364 (first received 15 August 2005).
Hoetzenecker 2005 {published data only}
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- Hoetzenecker W, Ecker R, Kopp T, Stuetz A, Stingl G, Elbe-Buerger A. Pimecrolimus selectively targets T cells in skin lesions of patients with atopic dermatitis. Journal of Investigative Dermatology 2005;124(4 Suppl):A42.
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Hung 2007 {published data only}
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- EUCTR2007-003106-99-DE. Pimecrolimus and epidermal barrier function: role for pimecrolimus in restoring skin barrier function and normalizing epidermal lipid content and differentiation in atopic epidermis: a randomized, intra-patient, double-blind (right/left arm) study in adults with atopic dermatitis treated with 1% pimecrolimus cream and 0.1% triamcinolone acetonide cream as treatment control twice daily for 3 weeks. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2007-003106-99-DE (first received 17 August 2007).
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- Jensen JM, Weppner M, Dahnhardt-Pfeiffer S, Folster-Holst R, Proksch E. Pimecrolimus cream treatment repairs skin barrier structure more effectively than triamcinolone acetonide (TCA) cream treatment in atopic dermatitis. Experimental Dermatology 2010;19(2):196.
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- CASM981C2402. An exploratory, randomized, double-blind, vehicle-controlled, multicenter, parallel dose study investigating the use of pimecrolimus cream 1% in mild to moderate atopic dermatitis patients who demonstrate a clinical insensitivity to topical glucocorticoid. www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=1453 (first received 25 September 2002).
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- EUCTR2005-000839-17-DE. A 16-week, randomized, multi-center, parallel-group, pimecrolimus-blinded, controlled study (4-week treatment period followed by 12-week observational period) to evaluate the safety of concomitant use of ASM 981 (pimecrolimus) cream 1% (BID) plus topical corticosteroid (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2005-000839-17-DE (first received 9 May 2006).
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- CASM981C2442. A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the safety and efficacy of pimecrolimus cream 1% in mild to moderate head and neck atopic dermatitis of patients intolerant of topical corticosteroid. www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2214 (first received 19 October 2004).
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- JapicCTI-152887. Phase II clinical study of JTE-052 - dose finding study in patients with atopic dermatitis. www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-152887 (first received 28 April 2015).
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- JapicCTI-173553. A phase II study of JTE-052 ointment in pediatric patients with atopic dermatitis. www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-173553 (first received 31 March 2017).
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- JapicCTI-173554. Phase III clinical study of JTE-052 - randomized controlled and long-term extension study in patients with atopic dermatitis. www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?japicId=JapicCTI-173554 (first received 31 March 2017).
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- EUCTR2018-003713-18-ES. Efficacy and safety study of ruxolitinib cream followed by a long term safety period in adolescents and adults with atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2018-003713-18-ES (first received 19 June 2019).
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- Ma L, Zhang L, Kobayashi M, Tao X, Qian Q, Cheng H, et al. Efficacy and safety of crisaborole ointment in Chinese and Japanese patients aged ≥ 2 years with mild-to-moderate atopic dermatitis. Journal of Dermatology 2020;50:847-55. - PubMed
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- NCT04530643. A phase II study of HY209 gel for atopic dermatitis patients (Shaperon). clinicaltrials.gov/show/NCT04530643 (first received 28 August 2020).
NCT04664153 {published data only}
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- EUCTR2020-003977-23-PL. A study of the efficacy, safety, tolerability and pharmacokinetics of PF07038124 ointment in participants with eczema or psoriasis. https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2020-003977-23-PL (date received 2020).
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Wolkerstorfer 1998 {published data only}
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- Wolkerstorfer A, Strobos MA, Glazenburg EJ, Mulder PG, Oranje AP. Fluticasone propionate 0.05% cream once daily versus clobetasone butyrate 0.05% cream twice daily in children with atopic dermatitis. Journal of the American Academy of Dermatology 1998;39(2 Pt 1):226-31. - PubMed
Woods 2011 {published data only}
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- NCT00819507. VANOS cream and skin barrier function. clinicaltrials.gov/ct2/show/NCT00819507 (first received 9 January 2009).
Wortzel 1975a {published data only}
-
- Wortzel MH. A new corticosteroid for moderate/severe dermatoses. Clinical Medicine 1975;82(3):23-6.
Wortzel 1975b {published data only}
-
- Wortzel MH. A new corticosteroid for moderate/severe dermatoses. Clinical Medicine 1975;82(3):23-6.
Wortzel 1975c {published data only}
-
- Wortzel MH. A new corticosteroid for moderate/severe dermatoses. Clinical Medicine 1975;82(3):23-6.
Wu 2013 {published data only}
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- Wu SH, Chen XQ, Liu B, Wu HJ, Dong L. Efficacy and safety of 15(R/S)-methyl-lipoxin A4 in topical treatment of infantile eczema. British Journal of Dermatology 2013;168(1):172-8. - PubMed
Yasuda 1976 {published data only}
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- Yasuda T. Clinical experiences with hydrocortisone 17-butyrate. Dermatologica 1976;152(Suppl 1):221-9. - PubMed
Yawalkar 1991 {published data only}
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- Yawalkar SJ, Schwerzmann L. Double-blind, comparative clinical trials with halobetasol propionate cream in patients with atopic dermatitis. Journal of the American Academy of Dermatology 1991;25(6 Pt 2):1163-6. - PubMed
Zane 2013 {published data only}
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- Murrell DF, Gebauer K, Spelman L, Zane LT. Crisaborole topical ointment, 2% in adults with atopic dermatitis: a phase 2a, vehicle-controlled, proof-of-concept study. Journal of Drugs in Dermatology 2015;14(10):1108‐12. - PubMed
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- NCT01301508. Efficacy and safety of AN2898 and AN2728 topical ointments to treat mild-to-moderate atopic dermatitis. clinicaltrials.gov/show/NCT01301508 (first received 23 February 2011).
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- Paller A, Yosipovitch G, Wynnis T, Lebwohl M, Boguniewicz M, Call R, et al. Crisaborole ointment improves global atopic dermatitis severity and provides early relief in pruritus: pooled results from two phase 3 clinical trials. Journal of the American Pharmacists Association 2017;57(3):not reported.
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- Zane L, Gogoleva T, Heerinckx F, Jermano J. AN2728 and AN2898 ointments demonstrate safety and efficacy in a bilateral study of atopic dermatitis. Journal of Dermatological Science 2013;69(2):e34.
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- Zane LT, Gebauer KA, Spelman L, Murrell DF, Varigos GA, Heerinckx FA, et al. Boron-based AN2728 and AN2898 ointments demonstrate safety and efficacy in a phase 2A bilateral study of mild-to-moderate atopic dermatitis. Wound Repair and Regeneration 2012;20(5):A69.
Zuberbier 2008 {published data only}
-
- CASM981CDE10. A 24-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study on pimecrolimus cream 1% assessing the steroid-sparing effect in the long term management of pediatric patients with severe atopic dermatitis. www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=1956 (first received 1 October 2003).
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- NCT00351052. Steroid-sparing effect with pimecrolimus in pediatric patients with atopic dermatitis. clinicaltrials.gov/show/NCT00351052 (first received 12 July 2006).
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- Zuberbier T, Brautigam M. Long-term management of facial atopic eczema with pimecrolimus cream 1% in paediatric patients with mild to moderate disease. Journal of the European Academy of Dermatology and Venereology : JEADV 2008;22(6):718‐21. - PubMed
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- Zuberbier T, Heinzerling L, Bieber T, Schauer U, Klebs S, Brautigam M. Steroid-sparing effect of pimecrolimus cream 1% in children with severe atopic dermatitis. Dermatology (Basel, Switzerland) 2007;215(4):325-30. - PubMed
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- Zuberbier T, Luger T, Thaci D, Werfel T, Kerscher M, Klebs S. Pimecrolimus cream 1% in the long term management of severe pediatric atopic eczema. Journal of the European Academy of Dermatology and Venereology : JEADV 2005;19(Suppl 2):1.
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Ashurst 1970 {published data only}
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Bergoend 1982 {published data only}
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- Bergoend H. Double-blind comparison of hydrocortisone butyrate and halcinonide. Gazette Medicale de France 1982;89(36):4477-8.
Berth‐Jones 2003 {published data only}
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Bieber 2021 {published data only}
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Binder 1972 {published data only}
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- Binder R, McCleary J. Comparison of fluocinonide in a double-blind study with betamethasone valerate. Current Therapeutic Research, Clinical and Experimental 1972;14(1):35-8. - PubMed
Bircher 2002 {published data only}
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- Bircher AJ, Niederer M, Hohl Ch, Surber Ch. Stealth triamcinolone acetonide in a phytocosmetic cream. British Journal of Dermatology 2002;146(3):531-2. - PubMed
Bleehen 1995 {published data only}
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- Bleehen SS, Chu AC, Hamann I, Holden C, Hunter JA, Marks R. Fluticasone propionate 0.05% cream in the treatment of atopic eczema: a multicentre study comparing once-daily treatment and once-daily vehicle cream application versus twice-daily treatment. British Journal of Dermatology 1995;133(4):592-7. - PubMed
Bloudek 2023 {published data only}
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- Bloudek L, Eichenfield LF, Silverberg JI, Joish VN, Lofland JH, Sun K, et al. Impact of ruxolitinib cream on work productivity and activity impairment and associated indirect costs in patients with atopic dermatitis: pooled results from two phase III studies. American Journal of Clinical Dermatology 2023;24(1):109-17. - PMC - PubMed
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- Eichenfield L, Augustin M, Armstrong A, Venturanza M, Kallender H, Gao J, et al. Effects of ruxolitinib cream on work productivity and activity impairment in patients with atopic dermatitis: 52-week pooled results from two phase 3 studies. Journal of Managed Care and Speciality Pharmacy 2022;28(10 A Suppl):S97.
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- Eichenfield LF, Augustin M, Armstrong AW, Venturanza ME, Kallender H, Gao J, et al. Effects of ruxolitinib cream on work productivity and activity impairment in patients with atopic dermatitis: 52-week pooled results from two phase III studies. British Journal of Dermatology 2022;187(3):e126-e127.
Boguniewicz 2008 {published data only}
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- Boguniewicz M, Eichenfield L, Hebert A, Jarratt M. A multicenter, randomized, vehicle-controlled clinical study to examine the efficacy and safety of MAS063DP nonsteroidal cream in the management of mild to moderate atopic dermatitis in infants and children. Journal of the American Academy of Dermatology 2007;56(2):AB69.
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- Boguniewicz M, Zeichner JA, Eichenfield LF, Hebert AA, Jarratt M, Lucky AW, et al. MAS063DP is effective monotherapy for mild to moderate atopic dermatitis in infants and children: a multicenter, randomized, vehicle-controlled study. Journal of Pediatrics 2008;152(6):854-9. - PubMed
Breneman 2006 {published data only}
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- Breneman D, Fleischer A, Abramovits W, Farber H. Tacrolimus ointment with and without topical steroids in patients with moderate to severe atopic dermatitis. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB88.
Buckley 1964 {published data only}
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- Buckley DB. Double-blind comparative trial of betamethasone 17-valerate and fluocinolone acetonide ointments. Journal of the Irish Medical Association 1964;55:45-7. - PubMed
Bureau 1963 {published data only}
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- Bureau Y, Barriere H, Litoux P, Bureau L. Trial of treatment of several dermatoses with betamethasone. Bulletin de la Societe Francaise de Dermatologie et de Syphiligraphie 1963;70:330-4. - PubMed
Camacho 1996 {published data only}
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- Camacho F, Garcia Bravo B, Diaz Perez JL, Aguirre A, Arnau C, Garcia Barbal J, et al. A comparative intraindividual double-blind assay between prednicarbate and fluocortolone in the management of atopic dermatitis (Spanish). Actas Dermo-Sifiliograficas 1996;87(1-2):59-63.
Caproni 2006 {published data only}
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- Caproni M, Torchia D, Antiga E, Volpi W, Fabbri P. Expression of adhesion molecules in atopic dermatitis is reduced by tacrolimus, but not by hydrocortisone butyrate: a randomized immunohistochemical study. Clinical and Experimental Dermatology 2006;31(6):813-7. - PubMed
Chiarenza 1982 {published data only}
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- Chiarenza A. Results of the use of diflorasone diacetate ointment in dermatology. Giornale Italiano di Dermatologia e Venereologia 1982;117(3):XIX-XXII. - PubMed
ChiCTR2000030216 {published data only}
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- ChiCTR2000030216. Clinical study of CAPCS gel in the treatment of atopic dermatitis. http://www.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030216 (date first received 25/02/2020).
ChiCTR2000030246 {published data only}
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- ChiCTR2000030246. Clinical research of treatment of atopic dermatitis with FuRui moisturizing cream combining with glucocorticoid topical. http://www.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030246 (date first received 26/02/2020).
Colpas 2010 {published data only}
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- Colpas PT, Miyashiro CA, Schalka S, Neto AG. Comparative study of non-inferiority of a moisturizer cream versus 1% hydrocortisone cream in children with atopic dermatitis. In: 24th World Congress of Dermatology, conference abstract (https://www.wcd2019milan-dl.org/abstract-book/assets/html/abstracts/05-a...). (accessed 22/07/24).
Cranswick 2006 {published data only}
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- Cranswick N. Vaccination response is equivalent in children with atopic dermatitis treated with 0.03% tacrolimus ointment or a hydrocortisone ointment regimen. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB84.
Danby 2014 {published data only}
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- Danby S, Brown K, Higgs-Bayliss T, Chittock J, Cork M. The effect of a complex emollient cream containing 5% urea, ceramide 3 and lactic acid, compared with a simple emollient, on the skin barrier in older people with dry skin. British Journal of Dermatology 2014;1:57-8.
Desmons 1977 {published data only}
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- Desmons F, Defrenne C. Clinical and biological trial of difluprednate in cream and gel forms in pediatric dermatology. Lille Medical 1977;22(9 Suppl 2):743-5. - PubMed
De Waure 2013 {published data only}
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- De Waure C, Cadeddu C, Venditti A, Barcella A, Bigardi A, Masci S, et al. Non steroid treatment for eczema: results from a controlled and randomized study. Giornale Italiano di Dermatologia e Venereologia 2013;148(5):471-7. - PubMed
Dhar Smalakar 1999 {published data only}
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- Dhar Smalakar S. Evaluation of the efficacy of topical doxepin, alone or in combination with topical corticosteroid, in the management of atopic dermatitis. Indian Journal of Dermatology 1999;44(2):58‐60.
Doherty 1979 {published data only}
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- Doherty JC, MacRae KD, Platt NE. Treatment of chronic eczemas. The comparative efficacy of two creams. Practitioner 1979;222(1330):561-3. - PubMed
Drake 1999 {published data only}
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- Drake LA, Cohen L, Gillies R, Flood JG, Riordan AT, Phillips SB, et al. Pharmacokinetics of doxepin in subjects with pruritic atopic dermatitis. Journal of the American Academy of Dermatology 1999;41(2I (2 Pt 1)):209-14. - PubMed
Durand 1975 {published data only}
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- Durand JR. Clinical trial of a mixture of neomycin, bacitracin, natamycin and dexamethasone. Mediterranee Medicale 1975;3(56):71-4.
Elgart 1978 {published data only}
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- Elgart ML, Hall JH, Clement ER, Bodian EL. Multicenter comparison of fluocinolone acetonide in an emollient cream base with betamethasone valerate cream. Cutis; Cutaneous Medicine for the Practitioner 1978;22(3):344-6.
EUCTR2005‐002803‐18‐LV {published data only}
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- EUCTR2005-002803-18-LV. Randomised, placebo-controlled, double-blind, efficacy study of the emollient V0034CR in addition to a moderately potent corticosteroid in the acute phase of treatment of atopic dermatitis in infants. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2005-002803-18-LV (first received 14 December 2005).
EUCTR2009‐010498‐19‐FR {published data only}
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- EUCTR2009-010498-19-FR. A multicenter, randomized, intra-individual, double blind, vehicle-controlled study to evaluate the efficacy and safety of CD2027 ointment 9 µg/g applied twice daily over 4 weeks in the treatment of target lesions in adults subjects with atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2009-010498-19-FR (first received 15 May 2009).
EUCTR2009‐012194‐35‐DE {published data only}
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- EUCTR2009-012194-35-DE. A single-center, randomized, controlled, observer-blind, phase IV study to develop the atopic localized eczema regression test (ALERT) using marketed topical corticosteroid formulations of different strength and the calcineurin inhibitors pimecrolimus (Elidel®) in patients with a pre-disposition for atopic dermatitis - atopic localized eczema regression test (ALERT). trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2009-012194-35-DE (first received 15 October 2009).
EUCTR2009‐017407‐28‐DE {published data only}
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- EUCTR2009-017407-28-DE. A phase II, single-center, randomized, controlled, double-blind study to assess effects on skin conditions and patient reported outcome of a topical formulation containing LAS41002 on lesional skin in patients with atopic eczema - AD. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2009-017407-28-DE (first received 18 December 2009).
Gip 1982 {published data only}
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- Gip L. A multi-centre evaluation of locoid and celestona valerate creams in the treatment of patients suffering from non-infected eczema. Current Therapeutic Research - Clinical and Experimental 1982;31(1):14‐9.
GP Medical Research 1967 {published data only}
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- GP Medical Research Unit. Treatment of eczemas and infected eczemas. British Journal of Clinical Practice 1967;21(10):505-7. - PubMed
GP Research Group {published data only}
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- General Practitioner Research Group. Topical corticosteroids in eczema. A comparative trial. Practitioner 1981;225(1353):410-1. - PubMed
Grejs 1978 {published data only}
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- Grejs J. Comparative trial of diflucortolon-21-valerate cream and hydrocortisone-17-butyrate cream in skin diseases. Therapie der Gegenwart 1978;117(12):1930-7. - PubMed
Guillot 1983 {published data only}
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- Guillot CF, Pizarro RM. Comparative double-blind study between hydrocortisone 17-butyrate vs. betamethasone 17-valerate in the treatment of no infected dermatosis. Archivos Argentinos de Dermatologia 1983;33(3):179-83.
Guttman‐Yassky 2017b {published data only}
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- Guttman-Yasky E, Yosipovitch G, Murrell D, Hanifin J. Crisaborole ointment provides early relief of pruritus in two phase 3 clinical trials in patients with mild or moderate atopic dermatitis. Acta Dermato-Venereologica 2017;97(8):1015‐6.
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- Guttman-Yassky E, Yosipovitch G, Murrell D, Hanifin J. Crisaborole ointment provides early relief of pruritus in two phase 3 clinical trials in patients with mild or moderate atopic dermatitis. Journal of Investigative Dermatology 2017;137(10 Suppl 2):S194.
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- Guttman-Yassky E, Yosipovitch G, Murrell D, Hanifin J. Crisaborole ointment provides early relief of pruritus in two phase 3 clinical trials in patients with mild or moderate atopic dermatitis. Pediatric Dermatology 2017;34(S1):S33-S34.
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- Guttman-Yassky E, Yosipovitch G, Murrell D, Hanifin J. Crisaborole ointment provides early relief of pruritus regardless of baseline disease severity in two phase 3 clinical trials in patients with mild or moderate AD. Journal of the American Academy of Dermatology 2017;76(6):AB86.
Hamada 1996 {published data only}
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- Hamada T, Ishii M, Nakagawa K, Kobayashi H, Kitajima J, Chanoki M, et al. Evaluation of the clinical effect of terfenadine in patients with atopic dermatitis. A comparison of strong corticosteroid therapy to mild topical corticosteroid combined with terfenadine administration therapy. Skin Research 1996;38(1):97-103.
Haneke 1992 {published data only}
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- Haneke E. The treatment of atopic dermatitis with methylprednisolone aceponate (MPA), a new topical corticosteroid. Journal of Dermatological Treatment 1992;3(Suppl 2):13-5.
Iraji 2022 {published data only}
IRCT2016102323235N5 {published data only}
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- IRCT2016102323235N5. The impact of Althaea officinalis formulation on controlling the symptoms of atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=IRCT2016102323235N5 (first received 21 December 2016).
Kamiya 2022 {published data only}
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- Kamiya K, Saeki H, Tokura Y, Yoshihara S, Sugai J, Ohtsuki M. Proactive versus rank-down topical corticosteroid therapy for maintenance of remission in pediatric atopic dermatitis: a randomized, open-label, active-controlled, parallel-group study (Anticipate study). Journal of Clinical Medicine 2022;11(21):6477. - PMC - PubMed
Kanof 1975 {published data only}
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- Kanof NB, Rosenberg EW. Fluocinide gel in atopic dermatitis. Cutis; Cutaneous Medicine for the Practitioner 1975;16(2):324-6.
Kassis 1982 {published data only}
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- Kassis V, Sondergaard J. Local treatment of non-infected bilateral eczema with Locoid (TM) and Celestoderm (TM): a double-blind comparison. Current Therapeutic Research, Clinical and Experimental 1982;31(3 II):446‐50.
Katsambas 1973 {published data only}
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- Katsambas A, Vareltzidis A. Therapeutic action of a new non-steroid drug (bufexamac) in the treatment of inflammatory dermatologic diseases. Double-blind clinical study. Bruxelles Medical 1973;53(8):463‐8. - PubMed
Kim 2013 {published data only}
Kircik 2009 {published data only}
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- Kircik L. Skin barrier function and hydration effects of hydrolipid cream alone and in combination in the treatment of mild to moderate atopic dermatitis: investigator-blinded, split-body, pilot study results. Journal of the American Academy of Dermatology 2009;60(3 Suppl 1):AB67.
Kwon 2019 {published data only}
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Lecomte 2003 {published data only}
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Lee 2021 {published data only}
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- Lee YW, Won CH, Jung K, Nam HJ, Choi G, Park YH, et al. Efficacy and safety of pac-14028 cream, a novel, topical, nonsteroidal, selective trpv1 antagonist in patients with mild to moderate atopic dermatitis: a phase iib randomized trial. Acta Dermato-Venereologica 2021;101(Suppl 221):31. - PMC - PubMed
Leeming 1974 {published data only}
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Lessard 1980 {published data only}
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- Lessard R, Labelle JL. Evaluation of desoximetasone 0.25% emollient cream in atopic dermatitis. Current Therapeutic Research - Clinical and Experimental 1980;27(2):247-54.
Liu 2000 {published data only}
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- Liu T, Shong KM, Zhang HS, Zhang XL, Zhang ZL, Mao Y, et al. A randomised controlled trial of prednisone versus kenacomb compound cream in the treatment of dermatitis and eczema (Chinese). Journal of Clinical Dermatology 2000;29(2):104-5.
Liu 2008 {published data only}
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- Liu SP, Huang XL, Fan CY. Effect observation of eczema treated with combined traditional Chinese medicine for external use with cetirizine and hydrocortisone butyrate. Southern China Journal of Dermato-Venereology 2008;15(3):161‐2.
Liu 2018 {published data only}
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- Liu L, Ong G. A randomized, open-label study to evaluate an intermittent dosing regimen of fluticasone propionate 0.05% cream in combination with regular emollient skin care in reducing the risk of relapse in pediatric patients with stabilized atopic dermatitis. Journal of Dermatological Treatment 2018;29(5):501-9. [DOI: 10.1080/09546634.2017.1401211] - DOI - PubMed
Liu 2022 {published data only}
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- Liu H, Gong X, Smith SH. LB991 Clinical serum biomarker profiling in TRuE-AD1 and TRuE-AD2 studies after 8 weeks of treatment with ruxolitinib cream. Journal of Investigative Dermatology 2022;142(8 Suppl):B27.
Londono 1976 {published data only}
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- Londono F. Halcinonide-neomycin-nystatin in the treatment of dermatosis and cutaneous candidiasis [Halcinonido-neomicina-nistanina en el tratamiento de dermatosis y candidiasis cutanea]. Medicina Cutanea Ibero-Latino-Americana 1976;4(6):463-7. - PubMed
Luderschmidt 1981 {published data only}
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- Luderschmidt C, Neubert U. On the treatment of eczema in practice. Combination therapy with econazole nitrate and triamcinolone acetonide. Zeitschrift fur Allgemeinmedizin 1981;57(28):1929‐34. - PubMed
Lundell 1974 {published data only}
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- Lundell ER, Koch E. A new corticosteroid preparation tested in a double-blind trial. Zeitschrift fur Allgemeinmedizin 1974;50(10):463-6. - PubMed
Lundell 1975 {published data only}
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- Lundell E. A double-blind trial of a new topical steroid formulation containing desoximetasone against fluocinolonacetonid cream. Zeitschrift fur Hautkrankheiten 1975;Suppl 2:17-9. - PubMed
Mackey 1974 {published data only}
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- Mackey JP. A double-blind clinical study of bufexamac and fluocinolone acetonide in dermatitis. Journal of the Irish Medical Association 1974;67(8):214-6. - PubMed
Mackey 1977 {published data only}
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- Mackey JP. Diflucortolone valerate and fluocinolone acetonide in eczema: a double-blind trial. Pharmatherapeutica 1977;1(7):462‐5.
Manusov 1974 {published data only}
-
- Manusov P, Van NF, Vinks P, Van ZE. A double-blind trial with two corticoid preparations (skin salves) in eczematous skin complaints. Folha Medica 1974;69(5):581‐3.
Marchesi 1994 {published data only}
-
- Marchesi E, Rozzoni M, Pini P, Cainelli T. Comparative study of mometasone furoate and betamethasone dipropionate in the treatment of atopic dermatitis. Giornale Italiano di Dermatologia e Venereologia 1994;129(1-2):9‐21.
Methaderm Study Group 1989 {published data only}
-
- Methaderm Study Group. Clinical effectiveness of topical 0.1% dexamethasone 17,21-dipropionate on lichenoid eczematous dermatitis. A comparison between 0.1% dexamethasone 17,21-dipropionate and 0.1% diflucortolone valerate under randomized comparative study. Skin Research 1989;31(5):705‐13.
Miki 1990 {published data only}
-
- Miki Y. Clinical study of methaderm cream on psoriasis, chronic eczema and atopic dermatitis: comparative study with 0.1% diflcortolone 21-valerate universal cream. Yakuri to Chiryo (Japanese Pharmacology and Therapeutics) 1990;18(12):5027‐37.
Morley 1976 {published data only}
-
- Morley N, Fry L, Walker S. Clinical evaluation of clobetasone butyrate in the treatment of children with atopic eczema, and its effect on plasma corticosteroid levels. Current Medical Research and Opinion 1976;4(3):223-8. - PubMed
Munro 1977 {published data only}
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- Munro DD, Robinson TW, Du Vivier AW, France DM, Clayton R, Sparkes CG. Betamethasone valerate ointment compared with fluocinonide FAPG. Archives of Dermatology 1977;113(5):599-601. - PubMed
NCT00106496 {published data only}
-
- NCT00106496. A multi-center study of short and long-term use of protopic ointment in patients with atopic dermatitis. clinicaltrials.gov/show/NCT00106496 (first received 28 March 2005).
NCT00185510 {published data only}
-
- NCT00185510. Efficacy and safety study of advantan for maintenance treatment of atopic dermatitis. clinicaltrials.gov/ct2/show/NCT00185510 (first received 16 September 2005).
NCT00480610 {published data only}
-
- NCT00480610. Treatment and control of atopic dermatitis with 0.1% tacrolimus ointment. clinicaltrials.gov/show/NCT00480610 (first received 31 May 2007).
NCT00568412 {published data only}
-
- NCT00568412. A clinical study in children and adolescents with mild to moderate atopic dermatitis. clinicaltrials.gov/show/NCT00568412 (first received 6 December 2007).
NCT00616538 {published data only}
-
- NCT00616538. Epiceram™ device versus mid-strength topical steroid (fluticasone propionate 0.05%) for treatment of atopic dermatitis. clinicaltrials.gov/show/NCT00616538 (first received 15 April 2008).
NCT00828412 {published data only}
-
- NCT00828412. Comparison of the efficacy and safety of two topical creams for pediatric atopic dermatitis. clinicaltrials.gov/show/NCT00828412 (first received 26 January 2009).
NCT00919763 {published data only}
-
- NCT00919763. Efficacy and safety study of CD2027 ointment 3 mcg/g twice daily treatment for adults with at least moderate atopic dermatitis. clinicaltrials.gov/show/NCT00919763 (first received 12 June 2009).
NCT01119313 {published data only}
-
- NCT01119313. Study to investigate skin conditions and patient assessment of LAS 41002 in the treatment of atopic eczema. clinicaltrials.gov/ct2/show/NCT01119313 (first received 7 May 2010).
NCT01429701 {published data only}
-
- NCT01429701. Effectiveness of polymyxin B sulphate + prednisolone + benzocaine + clioquinol in acute and sub-acute dermatitis eczematous. clinicaltrials.gov/show/NCT01429701 (first received 7 September 2011).
NCT01850849 {published data only}
-
- NCT01850849. Safety, tolerability and pharmacokinetics in AD subjects and healthy subjects of cutaneous application of LEO 39652 cream. clinicaltrials.gov/show/NCT01850849 (first received 10 May 2013).
NCT02426359 {published data only}
-
- NCT02426359. Safety and efficacy study of Q301 in moderate to severe atopic dermatitis patients. clinicaltrials.gov/show/NCT02426359 (first received 24 April 2015).
NCT02576938 {published data only}
-
- NCT02576938. A study of baricitinib (LY3009104) in participants with moderate-to-severe atopic dermatitis. clinicaltrials.gov/show/NCT02576938 (first received 15 April 2015).
NCT02582177 {published data only}
-
- NCT02582177. Effectiveness study of ketoconazole and betamethasone to treat fungal infection and dermatophytosis. clinicaltrials.gov/show/NCT02582177 (first received 21 October 2015).
NCT03059693 {published data only}
-
- Alex P, Sachdev M, Centola C, Shilpakar R, Williams S, Ramnane M, et al. Efficacy and safety of HAT1, a novel topical therapeutic: results from randomized, double-blind, placebo-controlled clinical trials in psoriasis and atopic dermatitis. Journal of the American Academy of Dermatology 2018;79(3):AB120.
-
- NCT03059693. Efficacy and tolerability of HAT1 in patients with moderate to severe atopic dermatitis. clinicaltrials.gov/show/NCT03059693 (first received 23 February 2017).
NCT03627767 {published data only}
-
- NCT03627767. Study to investigate efficacy and safety of PF-04965842 in subjects aged 12 years and over with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects. clinicaltrials.gov/ct2/show/NCT03627767 (first received 13 August 2018).
NCT03796676 {published data only}
-
- NCT03796676. JAK1 inhibitor with medicated topical therapy in adolescents with atopic dermatitis (JADE TEEN). clinicaltrials.gov/ct2/show/NCT03796676 (first received 8 January 2019).
NCT03859986 {published data only}
-
- NCT03859986. Study in subjects with moderate atopic dermatitis. clinicaltrials.gov/ct2/show/NCT03859986 (first received 1 March 2019).
NCT03911401 {published data only}
-
- NCT05149313. A study of lebrikizumab in combination with topical corticosteroids in participants having atopic dermatitis (AD) that are not adequately controlled or non-eligible for cyclosporine. https://www.clinicaltrials.gov/study/NCT05149313 (date received 2022).
NCT04490109 {published data only}
-
- NCT04490109. B244 topical spray for the treatment of pruritus in adults with a history of atopic dermatitis. https://clinicaltrials.gov/study/NCT04490109 (first received 2021).
NCT05018806 {published data only}
-
- NCT05018806. Proof of concept study of rilzabrutinib in adult patients with moderate-to-severe atopic dermatitis. https://clinicaltrials.gov/show/NCT05018806 (date first received 19/08/2021).
NCT05318300 {published data only}
-
- NCT05318300. Evaluation of an adapted formula on atopic dermatitis. https://clinicaltrials.gov/ct2/show/NCT05318300 (date first received 2023).
NCT05792826 {published data only}
-
- NCT05792826. Clinical study of BSZY cream intervention to relieve atopic facial dermatitis. https://www.clinicaltrials.gov/ct2/show/NCT05792826 (date first received 2023).
Okoshi 2022 {published data only}
Park 2022 {published data only}
-
- Park CW, Kim BJ, Lee YW, Won C, Park CO, Chung BY, et al. Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: phase 3, randomized, vehicle-controlled study (CAPTAIN-AD). Journal of Allergy and Clinical Immunology 2022;149(4):1340-7. - PubMed
Pellanda 2005 {published data only}
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- Pellanda C, Weber M, Bircher A, Surber C. Low-dose triamcinolone acetonide in the phytocosmetic lichtena reduces inflammation in mild to moderate atopic dermatitis. Dermatology (Basel, Switzerland) 2005;211(4):338-40. - PubMed
Queille 1984 {published data only}
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- Queille C, Pommarede R, Saurat JH. Efficacy versus systemic effects of six topical steroids in the treatment of atopic dermatitis of childhood. Pediatric Dermatology 1984;1(3):246-53. - PubMed
Reidhav 1996 {published data only}
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- Reidhav I, Svensson A. Betamethasone valerate versus mometasone furoate cream once daily in atopic dermatitis. Journal of Dermatological Treatment 1996;7(2):87-8.
Reyes 1977 {published data only}
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- Reyes JP. Topical treatment of inflammatory dermatoses and cutaneous candidiasis with a new corticosteroid antibiotic combination: halcinonide neomycin amphotericin. British Journal of Clinical Practice 1977;31(4):33-5. - PubMed
Rodriguez 1977 {published data only}
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- Rodriguez Moreno T, Rodriguez Canas T, Mestre JM. Topical treatment of eczema with flupamesone (Flutenal): a double blind comparison with betamethasone 17 valerate (method of simultaneous symmetrical paired comparisons). Current Therapeutic Research - Clinical and Experimental 1977;21(2):183-6. - PubMed
Ronnstad 2023 {published data only}
-
- Ronnstad AT, Bay L, Ruge IF, Halling AS, Fritz BG, Jakasa I, et al. Defining the temporal relationship between the skin microbiome, immune response and skin barrier function during flare and resolution of atopic dermatitis: protocol of a Danish intervention study. BMJ Open 2023;13(2):e068395. - PMC - PubMed
Roth 1973a {published data only}
-
- Roth HL, Gellin GA. Atopic dermatitis: treatment with a urea-corticosteroid cream. Cutis; Cutaneous Medicine for the Practitioner 1973;11(2):237-9.
Roth 1973b {published data only}
-
- Roth H, McCleary J. Double blind trial of fluocinonide cream in psoriasis and atopic dermatitis. Clinical Medicine 1973b;80(5):16-9.
Sandstrom 2006 {published data only}
-
- Sandstrom Falk MH, Sarnhult T, Hedner T, Faergemann J. Treatment of atopic dermatitis with 1% hydrocortisone and 25% pentane-1,5-diol: effect on Staphylococcus aureus. Acta Dermato-Venereologica 2006;86(4):372-3. - PubMed
Schmidt 1987 {published data only}
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- Schmidt H, Hjorth N, Holm P. Domoprednate, a new nonhalogenated topical steroid: comparison to hydrocortisone butyrate. Dermatologica 1987;175(3):145-7. - PubMed
Schneider 1977 {published data only}
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- Schneider C, Koch E. Double blind trial of an ointment containing fluprednylidene acetate plus salicylic acid against salicylic acid alone. Die Therapiewoche 1977;27(47):8610-4.
Schuttelaar 2003 {published data only}
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- Schuttelaar M. The addition of tetracyclin to triamcinolon ointment in atopic dermatitis: a randomized controlled trial. Journal of the European Academy of Dermatology and Venereology : JEADV 2003;17(Suppl 3):155‐6.
Sefton 1983e {published data only}
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- Sefton J, Galen WK, Nesbitt LT, Landow RK. Comparative efficacy of hydrocortisone valerate 0.2% cream and triamcinolone acetonide 0.1% cream in the treatment of atopic dermatitis. Current Therapeutic Research, Clinical and Experimental 1983;34(2 I):341‐4.
Snyder 2022 {published data only}
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- Snyder S, Collins A, Cline A, Bashyam A, Unrue E, Feldman S, et al. Measuring and improving adherence to crisaborole 2% ointment in patients with atopic dermatitis. Journal of Drugs in Dermatology 2022;21(10):1043-8. - PubMed
Stahle 1965 {published data only}
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- Stahle IO, Webb JG. Comparison of topical fluocinolone and tumenol prednisolone: a double-blind trial. Medical Journal of Australia 1965;2(10):418-20. - PubMed
Stahle 1965a {published data only}
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- Stahle IO, Webb JG. A comparative trial of full and half strength betamethasone 17-valerate cream. Australian Journal of Dermatology 1965;8(2):142-5. - PubMed
Strick 1975 {published data only}
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- Strick S. Comparison of two active topical preparations in psoriasis and atopic dermatitis. Cutis; Cutaneous Medicine for the Practitioner 1975;16(3):579-83.
Sudilovsky 1975 {published data only}
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- Sudilovsky A, Clewe TH. Comparative efficacy of halcinonide and fluocinonide creams in psoriasis and eszematous dermatoses. Journal of Clinical Pharmacology 1975;15(11-12):779-84. - PubMed
Suresh 2017 {published data only}
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- Suresh SH, Shenoy M, Bhat R, Dn B, Jv M, Km S, et al. A comparative study of safety and efficacy of tacrolimus topical ointment (biocon's formulation) versus protopic topical ointment (astellas pharma) in children and adults with atopic dermatitis. Journal of Investigative Dermatology 2017;137(10 Suppl 2):S200.
Takemura 1988 {published data only}
-
- Takemura T. Clinical study of methaderm ointment on atopic dermatitis: comparative study with 0.1% diflucortone valerate ointment. Kiso to Rinsho (the Clinical Report) 1988;22(10):3203‐10.
TCTR20220210004 {published data only}
-
- TCTR20220210004. A study of therapeutic equivalence of mometasone cream and elomet cream in eczema. https://www.thaiclinicaltrials.org/show/TCTR20220210004 (date first received 2022).
TCTR20220313002 {published data only}
-
- TCTR20220313002. The effectiveness of tiptajo cream for treatment of mild to moderate dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=TCTR20220313002 (date first received 2022).
Thaci 2010 {published data only}
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- Thaci D, Chambers C, Sidhu M, Dorsch B, Ehlken B, Fuchs S. Twice-weekly treatment with tacrolimus 0.03% ointment in children with atopic dermatitis: clinical efficacy and economic impact over 12 months. Journal of the European Academy of Dermatology and Venereology : JEADV 2010;24(9):1040‐6. - PubMed
Toda 1983 {published data only}
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- Toda K. Clinical study of new moco KOWA ointment in eczematous skin diseases: well controlled study in comparison with 0.06% betamethasone 17-valerate ointment. Yakuri to Chiryo (Japanese Pharmacology and Therapeutics) 1983;11(3):983-91.
Ueda 1989 {published data only}
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- Ueda H, Hayakawa R, Matsunaga K. Well-controlled comparative study and open clinical study of 0.05% hydrocortisone-17-butyrate ointment (TS-1020). Skin Research 1989;31(2):248-67.
Van der Meer 1997a {published data only}
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- Van der Meer JB, Glazenburg EJ, Muldeer PG, Eggnick HF, Coenraads PJ. Efficacy and safety of fluticasone propionate ointment in the long-term treatment of atopic dermatitis. Australasian Journal of Dermatology 1997;38(Suppl 2):235.
Van Halewijn 2023 {published data only}
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- Van Halewijn K, Van der Most F, Bohnen A, Pasmans S, Bindels P, Elshout G. Atopic dermatitis in children in primary care: baseline characteristics, medication use and severity measures in the Rotterdam Eczema Study. Allergy 2023;78(Suppl 111):375. - PubMed
Van Zuiden 1978 {published data only}
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- Van Zuiden E. Diflucortolone valerianate and fluocinolone acetonide in eczema and dermatitis. Interindividual randomized double-blind study with 124 patients. Therapie der Gegenwart 1978;117(8):1248-64. - PubMed
Venier 1982 {published data only}
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- Venier A, Carnevali P, Alessandrini A, Urbani S. Controlled clinical trial of a topical formulation of fluocortolone (as privalate and caproate esters) plus chlorquinaldol. Clinica Europea 1982;21(5):932-9.
Wang 1995 {published data only}
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- Wang JB, Jin HZ, Liu YH. Clinical observation on the efficacy of fluticasone propionate cream and ointment in the treatment of eczema. Chinese Journal of Dermatology 1995;28(2):128-9.
Wang 2003 {published data only}
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- Wang JB, Liu YH, Zhao G, Guo ZP, Tu YT, Maurice G. Hydrocortisone aceponate lipophilic cream has similar efficacy and safety to hydrocortisone butyrate lipocream in the treatment of endogenous eczema. Journal of the European Academy of Dermatology and Venereology : JEADV 2003;17(Suppl 3):347.
Weitgasser 1972a {published data only}
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- Weitgasser H. Experiences with a dexamethasone-nandrolonedekanoate creme. Wiener Medizinische Wochenschrift (1946) 1972;122(14):196‐8. - PubMed
Wilson 1973 {published data only}
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- Wilson L. Betamethasone 17-valerate ointment in a lanolin-free base. Current Medical Research and Opinion 1973;1(4):228-32. - PubMed
Xhauflaire‐Uhoda 2007 {published data only}
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- Xhauflaire-Uhoda E, Thirion L, Pierard-Franchimont C, Pierard GE. Comparative effect of tacrolimus and betamethasone valerate on the passive sustainable hydration of the stratum corneum in atopic dermatitis. Dermatology (Basel, Switzerland) 2007;214(4):328‐32. - PubMed
Zirwas 2017 {published data only}
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- Zirwas MJ, Barkovic S. Anti-pruritis efficacy of itch relift lotion and cream in patients with atopic history: comparison with hydroxortisone cream. Journal of Drugs in Dermatology 2017;16(3):243‐7. - PubMed
References to studies awaiting assessment
Bos 2002 {published data only}
-
- Bos J. Tacrolimus ointment (protopic) 0.03% twice daily as the therapy of choice in young paediatric patients (2-6 years) with moderate to severe AD. Annales de Dermatologie et de Venereologie 2002;129(Suppl 1 Pt 2):1S408.
ChiCTR2100043963 {published data only}
-
- ChiCTR2100043963. The role and application of skin microbiota and its metabolites in atopic dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100043963 (first received 06 March 2021).
ChiCTR2100044339 {published data only}
-
- ChiCTR2100044339. Experimental study on the effect of taxisan on colonization of Staphylococcus aureus in skin lesions of atopic dermatitis in vivo and in vitro. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100044339 (first received 16 March 2021).
ChiCTR2100053644 {published data only}
-
- ChiCTR2100053644. A single-center, randomized, blinded, desonide cream-controlled phase IV to evaluate the safety and efficacy of 2% cliborrol ointment combined with desonide cream for sequential use in patients with mild to moderate atopic dermatitis clinical research. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100053644 (first received 26 November 2021).
EUCTR2004‐004052‐39‐DK {published data only}
-
- EUCTR2004-004052-39-DK. Short-term growth in children with atopic dermatitis treated with tacrolimus and hydrocortisone-17-butyrate [Korttidsvækst hos børn med atopisk dermatitis behandlet med tacrolimus og hydrokortison-17-butyrat]. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2004-004052-39-DK (first received 28 October 2004).
EUCTR2005‐002471‐32‐GB {published data only}
-
- EUCTR2005-002471-32-GB. A phase II, single-centre, investigator-blind, parallel group clinical trial to investigate the efficacy and safety of 1% ciclopirox olamine (Batrafen® cream), compared to 1% hydrocortisone acetate (HC45® cream), compared to a topical emollient (E45® cream), in the treatment of patients with mild to moderate atopic eczema. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2005-002471-32-GB (first received 1 July 2005).
EUCTR2007‐002182‐12‐GB {published data only}
-
- EUCTR2007-002182-12-GB. A single center, single-blind, parallel group clinical trial to investigate the efficacy and safety of W0153 vs. standard moisturizer in the maintenance of patients with atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2007-002182-12-GB (first received 30 May 2007).
EUCTR2007‐007789‐39‐FR {published data only}
-
- EUCTR2007-007789-39-FR. Efficacy and safety comparison of CD4802 0.1% ointment versus vehicle in the treatment of target lesions in adults with atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2007-007789-39-FR (first received 17 March 2008).
EUCTR2011‐000917‐38‐DE {published data only}
-
- EUCTR2011-000917-38-DE. CBPR277X2101 A first-in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2011-000917-38-DE (first received 18 July 2011).
-
- NCT01428297. A study evaluating the safety and efficacy of topical BPR277 for the treatment of atopic dermatitis and netherton syndrome. https://clinicaltrials.gov/show/NCT01428297 (first received 2011).
Guo 2000 {published data only}
-
- Guo ZP, Zhou GP. A clinical controlled trial of laikede cream versus 0.1% eloson cream in the treatment of dermatitis and eczema. Journal of Clinical Dermatology 2000;29(2):109-10.
Gutgesell 1998 {published data only}
-
- Gutgesell C, Jung T, Reich K, Junghans V, Bohn M, Neumann C. Double-blind hydrocortisone-controlled tacrolimus ointment for atopic dermatitis. Journal of Investigative Dermatology 1998;110(4):681.
Hanifin 2002 {published data only}
-
- Hanifin J, Ho V, Kaufmann R, Kapp A, Honig P, Koo J, et al. Pimecrolimus (SDZ ASM 981) cream: good tolerability in paediatric patients. Annales de Dermatologie et de Venereologie 2002;129(Suppl 1 Pt 2):1S411.
JapicCTI‐205315 {published data only}
-
- JapicCTI-205315. A pharmacological study of tacrolimus ointment. trialsearch.who.int/Trial2.aspx?TrialID=JPRN-JapicCTI-205315 (first received 5 June 2020).
JPRN‐jRCT2031210012 {published data only}
-
- JPRN-jRCT2031210012. A pharmacological study of M1151C2. trialsearch.who.int/Trial2.aspx?TrialID=JPRN-jRCT2031210012 (first received 6 April 2021).
Koller 2023 {published data only}
-
- Koller N, Spelman L, Benson M, Bhoyrul B, Lee J, Abdulla EA, et al. Phase 2 trial of novel topical drug AB-101a for treatment of mild to moderate atopic dermatitis in children and adults. Pediatric Dermatology 2023;40(Supplement 2):892023.
Liu 2014a {published data only}
-
- Liu L, Zhu X, Zhao Z, Wang S, Ma L, Gu H, et al. Intermittent proactive maintenance treatment with 0.03% tacrolimus ointment in pediatric patients with moderate to severe atopic dermatitis: results from a multicenter, open-label, randomized, controlled study. Journal of Dermatology 2014;41:10.
NCT00392067 {published data only}
-
- EUCTR2006-001472-20-DK. LEO19123 cream in the treatment of atopic dermatitis. A phase II, proof of concept study, testing once daily use of two dose-combinations of LEO19123 cream (calcipotriol and LEO80122) in the treatment of atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2006-001472-20-DK (first received 14 July 2006).
-
- NCT00392067. Clinical Study Report: LEO 19123 cream in the treatment of atopic dermatitis. https://clinicaltrials.gov/study/NCT00392067 (date first received 24/10/2006).
-
- NCT00392067. LEO19123 cream in the treatment of atopic dermatitis. clinicaltrials.gov/show/NCT00392067 (first received 25 October 2006).
NCT00932074 {published data only}
-
- NCT00932074. A study to determine the safety, tolerability and efficacy of KP-413 in subjects with atopic dermatitis (AD). clinicaltrials.gov/ct2/show/NCT00932074 (first received 2 July 2009).
NCT01781663 {published data only}
-
- NCT01781663. Efficacy of KAM2904 face cream and KAM3008 body lotion treatment in children with atopic dermatitis (AD). clinicaltrials.gov/show/NCT01781663 (first received 1 February 2013).
NCT03089229 {published data only}
-
- CTRI/2017/05/008636. To evaluate the effectiveness of MetaDerm HAT01H cream in atopic dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2017/05/008636 (first received 23 May 2017).
-
- NCT03089229. A study to evaluate the efficacy and safety of HAT01H in atopic dermatitis. clinicaltrials.gov/show/NCT03089229 (first received 24 March 2017).
NCT03134352 {published data only}
-
- NCT03134352. Study to evaluate the efficacy and safety of ZL-3101 in subjects with subacute eczema. clinicaltrials.gov/ct2/show/NCT03134352 (first received 28 April 2017).
NCT04753034 {published data only}
-
- NCT04753034. Study of TER-101 topical ointment in subjects with atopic dermatitis. clinicaltrials.gov/show/NCT04753034 (first received 12 February 2021).
Ruzicka 2002b {published data only}
-
- Ruzicka T. Paediatric patients with moderate to severe atopic dermatitis treated with tacrolimus ointment 0.03% show minimal systemic exposure. Annales de Dermatologie et de Venereologie 2002;129(Suppl 1 Pt 2):1S421.
Szybejko‐Machaj 2002 {published data only}
-
- Szybejko-Machaj G, Kubicka W, Kolodziej T, Bialynicki-Birula R. Pentoxifylline therapy of acute atopic dermatitis. Journal of the European Academy of Dermatology and Venereology: JEADV 2002;16(Suppl s1):132.
Wang 2014 {published data only}
-
- Wang F, Cao G-L, Qi S-L, Zhang X-T, Zhang X-Q. Clinical observation of calcipotriol betamethasone ointment in the treatment of chronic eczema. Journal of Clinical Dermatology 2014;43(3):179-81.
References to ongoing studies
ACTRN12616000294459 {published data only}
-
- ACTRN12616000294459. A phase I, safety, tolerability and efficacy study of topical AKP-11 administration to participants with atopic dermatitis. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370241 (first received 06/07/2023).
ACTRN12617000763347 {published data only}
-
- ACTRN12617000763347. A phase II, safety, tolerability and efficacy study of topical AKP-11 administration to participants with atopic dermatitis. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372955 (date first received 17/05/2017).
Bos 2000 {published data only}
-
- Bos JD, Meyer K, De Vries HJ, Molloy S, Kandra A, Graeber M. Long-term safety and efficacy of SDZ ASM 981 cream in adult patients with atopic dermatitis. British Journal of Dermatology 2000;143(Suppl 57):34.
ChiCTR2100054661 {published data only}
-
- ChiCTR2100054661. Comparative study on the efficacy and safety of 0.03% tacrolimus ointment and 2% criborol ointment in the treatment of moderate atopic dermatitis in children. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2100054661 (date first received 23/12/2021).
ChiCTR2200059419 {published data only}
-
- ChiCTR2200059419. Phase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR2200059419 (date first received 29/04/2022).
ChiCTR2200060584 {published data only}
-
- ChiCTR2200060584. A randomized controlled study comparing the efficacy and safety of 2% crisaborole ointment versus 1% pimemollimus cream in the treatment of mild to moderate atopic dermatitis in children aged 2 years and older. https://www.chictr.org.cn/showprojEN.html?proj=164592 (first received 05 June 2022).
ChiCTR‐IPR‐17013807 {published data only}
-
- ChiCTR-IPR-17013807. Efficacy and safety of calcineurin inhibitors compared with that of glucocorticoid for the treatment of atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-IPR-17013807 (first received 10 December 2017).
ChiCTR‐TRC‐09000738 {published data only}
-
- ChiCTR-TRC-09000738. A clinical trial of tacrolimus as a therapeutic agent for atopic dermatitis in Chinese children: objective assessment of clinical efficacy in itch reduction and immunomodulatory effects. trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-TRC-09000738 (first received 4 May 2010).
ChiCTR‐TRC‐12002479 {published data only}
-
- ChiCTR-TRC-12002479. 0.03% Tacrolimus ointment long-term intermittent maintain treatment of children with moderate to severe atopic dermatitis multicenter, open, randomized, controlled study. trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-TRC-12002479 (first received 21 September 2014).
ChiCTR‐TRC‐12002591 {published data only}
-
- ChiCTR-TRC-12002591. Optimization of light, moderate to severe atopic dermatitis treatment strategies of the stabilization period: multicenter, open, randomized controlled study. trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-TRC-12002591 (first received 16 September 2012).
CTRI/2012/05/002636 {published data only}
-
- CTRI/2012/05/002636. A study to evaluate effectiveness of tacrolimus 0.1% topical ointment in the patients of the allergic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2012/05/002636 (first received 9 May 2012).
CTRI/2018/11/016407 {published data only}
-
- CTRI/2018/11/016407. A randomized, double-blind, placebo-controlled, three arms, parallel-group, multiple-site bioequivalence study with clinical endpoints. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2018/11/016407 (first received 22 November 2018).
CTRI/2022/07/043740 {published data only}
-
- CTRI/2022/07/043740. A clinical trial to study the effects of two drugs, tofacitinib 2% w/w ointment and 0.1% hydrocortisone butyrate ointment in patients suffering from dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2022/07/043740 (first received 05 July 2022).
CTRI/2022/07/044136 {published data only}
-
- CTRI/2022/07/044136. Effect of tofacitinib ointment 2% w/w compared to pimecrolimus cream 1% w/w in patients with mild to moderate atopic dermatitis (AD). https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2022/07/044136 (first received 19 July 2022).
CTRI/2022/08/045019 {published data only}
-
- CTRI/2022/08/045019. A randomized, double-blind, vehicle-controlled, three arm, parallel group, multi-centric, clinical study to establish the therapeutic equivalence of tacrolimus 0.03% topical ointment of Intas Pharmaceuticals Limited with protopic® 0.03% topical ointment in patients with moderate to severe atopic dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2022/08/045019 (first received on 29 August 2022).
CTRI/2022/08/045020 {published data only}
-
- CTRI/2022/08/045020. A study to establish the therapeutic equivalence of tacrolimus 0.1 % topical ointment in adult patients with moderate to severe atopic dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2022/08/045020 (first received 29 August 2022).
CTRI/2022/12/047916 {published data only}
-
- CTRI/2022/12/047916. An investigator initiated, randomized, placebo and active controlled, evaluator blinded study to assess the efficacy and tolerability of pimecrolimus lotion 0.8% (ENZ001) in the treatment of target lesions in patients with moderate atopic dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2022/12/047916 (first received 6/12/2022).
CTRI/2023/05/052282 {published data only}
-
- CTRI/2023/05/052282. A double-blind, randomized, placebo-controlled, three-arm, parallel-group, multi-centre clinical study to evaluate the safety and clinical endpoint bioequivalence of tacrolimus ointment 0.1% w/w of JAMP Pharma Corporation, Canada and protopic® tacrolimus ointment, 0.1% (w/w) of LEO Pharma Inc., Thornhill, Ontario, L3T 7W8 and compare both active treatments to a placebo control in the treatment of non-immunocompromised patients with moderate to severe atopic dermatitis. https://ctri.nic.in/Clinicaltrials/advsearch.php (first received May 2023).
CTRI/2023/06/054208 {published data only}
-
- CTRI/2023/06/054208. Study to evaluate safety, efficacy of topical 1% AKP-11 in atopic dermatitis participants. https://ctri.nic.in/Clinicaltrials/pubview2.php (first received 2023).
EUCTR2004‐001644‐80‐HU {published data only}
-
- EUCTR2004-001644-80-HU. Clinical study on tacrolimus ointment over the long-term “Control Study - Children” Revised version of FG-506-06-39 - Control Study - Children. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2004-001644-80-HU (first received 3 August 2004).
EUCTR2004‐002477‐23‐BE {published data only}
-
- EUCTR2004-002477-23-BE. Comparative, multicentre, randomised, double-blind study to assess the efficacy of tacrolimus 0.1% ointment versus fluticasone 0.005% ointment in adult patients suffering from moderate to severe atopic dermatitis and presenting with so-called "red face" lesions of the head and neck. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2004-002477-23-BE (first received 11 July 2005).
EUCTR2004‐002478‐47‐BE {published data only}
-
- EUCTR2004-002478-47-BE. Comparative, multicentre, randomised, double-blind study to assess the efficacy of tacrolimus 0.03% ointment versus fluticasone 0.005% ointment in children aged 2 years or over suffering from moderate to severe atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2004-002478-47-BE (first received 6 July 2005).
EUCTR2004‐004824‐11‐DE {published data only}
-
- EUCTR2004-004824-11-DE. Role for pimecrolimus in restoring skin barrier function and normalizing epidermal lipid content and differentiation in atopic epidermis: a randomized, intra-patient, double-blind (right/left arm) study in adults with atopic dermatitis treated with 1% pimecrolimus cream and 0.1 % betamethasone cream as treatment control twice daily for 3 weeks. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2004-004824-11-DE (first received 4 October 2005).
EUCTR2011‐006236‐23‐PL {published data only}
-
- EUCTR2011-006236-23-PL. A randomized, double-blind, placebo-controlled, three-arm, parallel assignment, multi-centre, therapeutic equivalence study of two tacrolimus 0.1% topical ointment formulations in adult patients with moderate to severe atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2011-006236-23-PL (first received 17 April 2012).
EUCTR2013‐000715‐25‐DE {published data only}
-
- EUCTR2013-000715-25-DE. Comparison of defined skin parameters in two comparable lesional skin areas after topical treatment with Soventol HydroCort 1% cream or vehicle. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2013-000715-25-DE (first received 26 April 2013).
EUCTR2014‐005593‐11‐AT {published data only}
-
- EUCTR2014-005593-11-AT. Diacerein for the treatment of atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2014-005593-11-AT (first received 13 January 2015).
EUCTR2016‐003013‐96‐DK {published data only}
-
- EUCTR2016-003013-96-DK. Avexxin (AVX001) 3% ointment (NG) in atopic dermatitis - safety and efficacy study. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2016-003013-96-DK (first received 27 July 2016).
EUCTR2018‐004370‐96‐DK {published data only}
-
- EUCTR2018-004370-96-DK. The effects of topical corticosteroid use on insulin sensitivity and bone turnover. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2018-004370-96-DK (first received 17 December 2018).
EUCTR2019‐002686‐35‐DE {published data only}
-
- EUCTR2019-002686-35-DE. Clinical study to compare two cutaneous ointments with the active substance methylprednisolone aceponate 0.1% and one cutaneous ointment without active substance for patients with atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2019-002686-35-DE (first received 9 June 2021).
Hanifin 2006 {published data only}
-
- Hanifin J. A novel topical nuclear factor kappa-B decoy: results from a phase I/II trial in atopic dermatitis. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB4.
IRCT20091012002581N6 {published data only}
-
- IRCT20091012002581N6. Comparison of efficacy of tacrolimus 0.03% ointment with mometason ointment in treatment of pediatric atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=IRCT20091012002581N6 (first received 25 November 2019).
ISRCTN27411543 {published data only}
-
- ISRCTN27411543. A randomised double-blinded cross-over trial comparing betamethasone valerate and tacrolimus ointment for the treatment of moderate to severe atopic eczema. trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN27411543 (first received 30 September 2004).
JapicCTI‐121946 {published data only}
-
- JapicCTI-121946. A phase 2a study of M520102 in atopic dermatitis patients. trialsearch.who.int/Trial2.aspx?TrialID=JPRN-JapicCTI-121946 (first received 4 September 2012).
JapicCTI‐173484 {published data only}
-
- JapicCTI-173484. A multicenter, randomized, double-blind, vehicle-controlled, parallel-group trial to assess the safety and efficacy of 0.3% and 1% OPA-15406 ointments when administered for 4 weeks in pediatric patients with atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=JPRN-JapicCTI-173484 (first received 6 January 2017).
JPRN‐jRCT2031210255 {published data only}
-
- JPRN-jRCT2031210255. Phase 3 clinical study of JTE-061 cream - randomized vehicle-controlled study (Part 1) and extension study (Part 2) in patients with atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=JPRN-jRCT2031210255 (first received 18 August 2021).
JPRN‐UMIN000006955 {published data only}
-
- JPRN-UMIN000006955. The effect of proactive therapy with tacrolimus and betamethasone butyrate on atopic dermatitis: randomized placebo-controlled study. trialsearch.who.int/Trial2.aspx?TrialID=JPRN-UMIN000006955 (first received 26 December 2011).
JPRN‐UMIN000022212 {published data only}
-
- JPRN-UMIN000022212. A clinical trial of the effects of topical steroid cream (PVA-N11) on atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=JPRN-UMIN000022212 (first received 6 May 2016).
NCT00120302 {published data only}
-
- NCT00120302. Quality of life study in adults with facial eczema. clinicaltrials.gov/show/NCT00120302 (first received 15 July 2005).
NCT00121381 {published data only}
-
- NCT00121381. Pimecrolimus cream 1% plus topical corticosteroid in patients (2-17 years of age) with severe atopic dermatitis. clinicaltrials.gov/show/NCT00121381 (first received 21 July 2005).
NCT00125333 {published data only}
-
- NCT00125333. Topical NF-kappaB decoy in the treatment of atopic dermatitis. clinicaltrials.gov/show/NCT00125333 (first received 1 August 2005).
NCT00354510 {published data only}
-
- EUCTR2005-005430-12-GB. Randomised, double-blind, placebo-controlled study of topical GW842470X formulation in adult patients with moderate atopic dermatitis. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2005-005430-12-GB (first received 10 March 2006).
-
- NCT00354510. Topical GW842470X in adults patients with moderate atopic dermatitis. clinicaltrials.gov/show/NCT00354510 (first received 20 July 2006).
NCT00356642 {published data only}
-
- NCT00356642. Study of single and ten day repeat atopical applications of GW842470X cream on the skin of patients with atopic dermatitis. clinicaltrials.gov/show/NCT00356642 (first received 26 July 2006).
NCT00510003 {published data only}
-
- NCT00510003. Assessment of pruritus improvement with pimecrolimus treatment on the areas affected by mild-to-moderate AD, in patients 2- to 11- year-old. clinicaltrials.gov/show/NCT00510003 (first received 1 August 2007).
NCT00689832 {published data only}
-
- NCT00689832. Protopic ointment in children [with] atopic eczema. clinicaltrials.gov/show/NCT00689832 (first received 4 June 2008).
NCT00690105 {published data only}
-
- NCT00690105. Protopic ointment in adult atopic eczema of the face. clinicaltrials.gov/show/NCT00690105 (first received 4 June 2008).
NCT00833079 {published data only}
-
- NCT00833079. Bioequivalence of two tacrolimus 0.1% topical ointment formulations in patients with atopic dermatitis. clinicaltrials.gov/show/NCT00833079 (first received 30 January 2009).
NCT00944632 {published data only}
-
- NCT00944632. Dose escalation of different concentrations of ZK 245186 in atopic dermatitis. clinicaltrials.gov/show/NCT00944632 (first received 23 July 2009).
NCT00946478 {published data only}
-
- NCT00946478. Effect of pimecrolimus cream on cathelicidin levels in subjects with eczema. clinicaltrials.gov/show/NCT00946478 (first received 27 July 2009).
NCT00980135 {published data only}
-
- NCT00980135. Sinecort pilot efficacy study. clinicaltrials.gov/show/NCT00980135 (first received 18 September 2009).
NCT01228513 {published data only}
-
- NCT01228513. Efficacy and safety of different concentrations of ZK245186 in atopic dermatitis (AD). clinicaltrials.gov/ct2/show/NCT01228513 (first received 26 October 2010).
NCT01359787 {published data only}
-
- NCT01359787. Efficacy and safety of different concentrations of mapracorat ointment over 4 weeks in atopic dermatitis (AD). clinicaltrials.gov/show/NCT01359787 (first received 25 May 2011).
NCT01567995 {published data only}
-
- NCT01567995. Randomised, double-blind, placebo-controlled study of topical clobetasone butyrate 0.05% cream in subjects with eczema for two weeks to evaluate the efficacy and safety. clinicaltrials.gov/show/NCT01567995 (first received 2 April 2012).
NCT01993420 {published data only}
-
- NCT01993420. A safety and efficacy of DRM02 in subjects with atopic dermatitis. clinicaltrials.gov/ct2/show/NCT01993420 (first received 25 November 2013).
NCT02079688 {published data only}
-
- NCT02079688. Efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics study of the topical formulation SB011 applied to lesional skin in patients with atopic eczema. clinicaltrials.gov/show/NCT02079688 (first received 6 March 2014).
NCT02219633 {published data only}
-
- NCT02219633. Effect of LEO 39652 cream in adults with mild to moderate atopic dermatitis (AD). clinicaltrials.gov/show/NCT02219633 (first received 19 August 2014).
NCT02496546 {published data only}
-
- NCT02496546. An explorative trial evaluating the effect of LEO 32731 cream in adults with mild to moderate atopic dermatitis. clinicaltrials.gov/show/NCT02496546 (first received 14 July 2015).
NCT02601703 {published data only}
-
- NCT02601703. To study generic tacrolimus ointment, 0.1% in the treatment of moderate to severe atopic dermatitis (inflammation of skin: itchy, red, swollen, and cracked skin). clinicaltrials.gov/show/NCT02601703 (first received 10 November 2015).
NCT02732314 {published data only}
-
- NCT02732314. Efficacy and tolerability of new topical formulations in subjects with atopic dermatitis. clinicaltrials.gov/show/NCT02732314 (first received 8 April 2016).
NCT02865356 {published data only}
-
- NCT02865356. Topical solution for the treatment of atopic dermatitis (CYCLATOP). clinicaltrials.gov/ct2/show/NCT02865356 (first received 12 August 2016).
NCT02949960 {published data only}
-
- NCT02949960. DMT210 topical gel in the treatment of atopic dermatitis. clinicaltrials.gov/show/nct02949960 (first received 31 October 2016).
NCT03002571 {published data only}
-
- NCT03002571. Efficacy and safety of IDP-124 lotion. clinicaltrials.gov/show/NCT03002571 (first received 23 December 2016).
NCT03058783 {published data only}
-
- NCT03058783. Efficacy and safety of IDP-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects. clinicaltrials.gov/show/NCT03058783 (first received 23 February 2017).
NCT03394677 {published data only}
-
- NCT03394677. Study of RVT-501 topical ointment in pediatric patients with atopic dermatitis. clinicaltrials.gov/show/NCT03394677 (first received 9 January 2018).
NCT03832010 {published data only}
-
- NCT03832010. Steroid-reducing effects of crisaborole. clinicaltrials.gov/show/NCT03832010 (first received 6 February 2019).
NCT03868098 {published data only}
-
- NCT03868098. Different application rates of crisaborole ointment 2% in adults with mild to moderate atopic dermatitis. clinicaltrials.gov/ct2/show/NCT03868098 (first received 8 March 2019).
NCT04008784 {published data only}
-
- NCT04008784. Improvement of short term outcome of mild to moderate atopic dermatitis using a combination of crisaborole and a concomitant topical corticosteroid over a 8 week period. clinicaltrials.gov/show/NCT04008784 (first received 5 July 2019).
NCT04194814 {published data only}
-
- NCT04194814. Skin bioMARkers for atopic eczema therapy evaluation (SMART). clinicaltrials.gov/show/NCT04194814 (first received 11 December 2019).
NCT04313400 {published data only}
-
- NCT04313400. Topically applied AMTX-100 CF for adult patients with mild to moderate atopic dermatitis. clinicaltrials.gov/show/NCT04313400 (first received 18 March 2020).
NCT04435392 {published data only}
-
- NCT04435392. Jaktinib hydrochloride cream for atopic dermatitis. clinicaltrials.gov/show/NCT04435392 (first received 17 June 2020).
NCT04598269 {published data only}
-
- NCT04598269. Study of ATI-1777 in adult patients with moderate or severe atopic dermatitis. clinicaltrials.gov/ct2/show/NCT04598269 (first received 22 October 2020).
NCT04615962 {published data only}
-
- NCT04615962. Topical cream SNG100 for treatment in moderate atopic dermatitis subjects. clinicaltrials.gov/show/NCT04615962 (first received 4 November 2020).
NCT04717310 {published data only}
-
- NCT04717310. Evaluate the efficacy and safety of topical SHR0302 ointment in patients with mild-to-moderate atopic dermatitis. clinicaltrials.gov/show/NCT04717310 (first received 22 January 2021).
NCT04737304 {published data only}
-
- EUCTR2020-003143-28-GB. A first-in-human trial to investigate how safe, tolerable, effective and how the body handles BEN2293 in patients who have mild to moderate eczema. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2020-003143-28-GB (first received 6 August 2020).
-
- NCT04737304. A first-in-human PoC study with BEN2293 in patients with mild to moderate atopic dermatitis. clinicaltrials.gov/ct2/show/NCT04737304 (first received 3 February 2020).
NCT04845620 {published data only}
-
- EUCTR2021-006903-14-PL. A phase 3, 4-week, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-151 cream 0.05% administered QD in subjects with atopic dermatitis. https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2021-006903-14-PL (first received 2021).
-
- NCT04845620. Trial of PDE4 inhibition with roflumilast for the management of atopic dermatitis (integument-PED). clinicaltrials.gov/show/NCT04845620 (first received 15 April 2021).
NCT04921969 {published data only}
-
- NCT04921969. A study to assess the efficacy and safety of ruxolitinib cream in children with atopic dermatitis (TRuE-AD3). clinicaltrials.gov/show/NCT04921969 (first received 10 June 2021).
NCT04992546 {published data only}
-
- NCT04992546. Phase 2a study of the safety, tolerability, and pharmacokinetics of topically administered PRN473 (SAR444727) in patients with mild to moderate atopic dermatitis. clinicaltrials.gov/ct2/show/NCT04992546 (first received 5 August 2021).
NCT05127421 {published data only}
-
- NCT05127421. Ruxolitinib cream in participants with facial and/or neck atopic dermatitis involvement. clinicaltrials.gov/show/NCT05127421 (first received 19 November 2021).
NCT05200403 {published data only}
-
- NCT05200403. Improvement In scratch behavior and sleep in patients with atopic dermatitis. clinicaltrials.gov/show/NCT05200403 (first received 20 January 2022).
NCT05324618 {published data only}
-
- NCT05324618. Tacrolimus versus hydrocortisone in atopic dermatitis. https://clinicaltrials.gov/study/NCT05324618 (first received 16 January 2022).
NCT05326672 {published data only}
-
- NCT05326672. Phase III clinical study of benvitimod cream in the treatment of mild to moderate atopic dermatitis. https://clinicaltrials.gov/study/NCT05326672 (first received 06 April 2022).
NCT05375955 {published data only}
-
- NCT05375955. A study to learn about the study medicine (PF-07038124) in patients with mild to moderate atopic dermatitis or mild to severe plaque psoriasis. https://clinicaltrials.gov/study/NCT05375955 (first received 11 May 2022).
NCT05432596 {published data only}
-
- NCT05432596. Study of ATI-1777 in patients 12 to 65 years old with mild to severe atopic dermatitis. https://clinicaltrials.gov/study/NCT05432596 (first received 01 June 2022).
NCT05487963 {published data only}
-
- NCT05487963. Tolerability and effectiveness of CGB-500 topical ointment, 1% tofacitinib, for the treatment of atopic dermatitis. https://clinicaltrials.gov/study/NCT05487963 (first received 01 August 2022).
NCT05579899 {published data only}
-
- NCT05579899. Safety and efficacy study of EVO101 topical cream in atopic dermatitis. https://clinicaltrials.gov/study/NCT05579899 (first received 11 October 2022).
NCT05607901 {published data only}
-
- NCT05607901. A comparative clinical trial evaluating the effect and safety of tacrolimus versus hydrocortisone. https://clinicaltrials.gov/study/NCT05607901 (first received 28 October 2022).
NCT05608343 {published data only}
-
- NCT05608343. A phase 3, randomized, double-blind, vehicle-controlled, multicenter study to assess the efficacy and safety of difamilast ointment 1% in children, adolescents, and adults with mild to moderate atopic dermatitis. https://clinicaltrials.gov/study/NCT05608343 (first received 01 November 2022).
NCT05650320 {published data only}
-
- NCT05650320. To demonstrate the superiority of IMP (0.3% and 1% OPA-15406 ointment) versus the vehicle in pediatric patients with AD. https://clinicaltrials.gov/study/NCT05650320 (first received 06 December 2022).
NCT05667623 {published data only}
-
- NCT05667623. To demonstrate the superiority of IMP (1% OPA-15406 ointment) to the vehicle in adult patients with AD. https://clinicaltrials.gov/study/NCT05667623 (first received 02 December 2022).
NCT05729074 {published data only}
-
- NCT05729074. A study to evaluate the safety, tolerability and pharmacokinetic properties of IN-A002 ointment in healthy adult male volunteers and mild to moderate atopic dermatitis patients. https://clinicaltrials.gov/study/NCT05729074 (first received 25/01/2023).
NCT05843422 {published data only}
-
- NCT05843422. A first-in-human study of QY211 gel in adult subjects. https://classic.clinicaltrials.gov/ct2/show/NCT05843422 (first received 24/04/2023).
NCT05870865 {published data only}
-
- NCT05870865. A study to evaluate the anti-pruritic effectiveness of ASN008 in adults with mild to moderate atopic dermatitis. https://ichgcp.net/clinical-trials-registry/NCT05870865 (first received 30/03/2023).
Piscitelli 2018 {published data only}
-
- Piscitelli S, Lee J, McHale K, Collins J, Gillmor D, Tabolt G, et al. Cerdulatinib (DMVT-502), a novel, topical dual Janus kinase/spleen tyrosine kinase inhibitor, improves the cellular and molecular cutaneous signature in patients with atopic dermatitis. Experimental Dermatology 2018;27:44‐5.
Rhemus 2006 {published data only}
-
- Rhemus W, Kim J, Kern D, Murase J. A double-blind, placebo-controlled study of a natural topical anti-inflammatory for treatment of atopic dermatitis and psoriasis. Journal of the American Academy of Dermatology 2006;54(3 Suppl):AB210.
Schlesinger 2020 {published data only}
-
- Schlesinger T, Nduaka C, Elstrom T. Improvement of short-term outcome of mild to moderate atopic dermatitis using a combination treatment of crisaborole ointment 2% and a concomitant topical cortiscosteroid over a 8 week period. Journal of the American Academy of Dermatology 2020;83(6):AB211.
Van Halewijn 2018 {published data only}
-
- EUCTR2017-001525-40-NL. Effectiveness of different strengths of hormone cream: providing evidence for a better treatment strategy in children with eczema in general practice. trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2017-001525-40-NL (first received 30 May 2017).
-
- Halewijn K, Van Der Most F, Bohnen A, Pasmans S, Bindels P, Elshout G. Atopic dermatitis in children in the general population: baseline characteristics, medication use, and severity measures in the Rotterdam Eczema study. Allergy 2023;78(Supplement 111):375. - PubMed
-
- NTR6679. Effectiveness of different strengths of topical steroids in children with eczema in general practice. trialsearch.who.int/Trial2.aspx?TrialID=NTR6679 (first received 30 August 2017).
-
- Van Halewijn KF, Bohnen AM, Van Den Berg PJ, Pasmans Sgma, Bindels PJ, Elshout G. Different potencies of topical steroids for children with eczema: protocol for an observational cohort study with embedded randomized controlled trial. British Journal of Dermatology 2018;179(1):e55.
-
- Van Halewijn KF, Bohnen AM, Van den Berg PJ, Pasmans SGMA, Bindels PJE, Elshout G. Different potencies of topical corticosteroids for a better treatment strategy in children with atopic dermatitis (the Rotterdam Eczema study): protocol for an observational cohort study with an embedded randomised open-label controlled trial. BMJ Open 2019;9(6):e027239. - PMC - PubMed
Additional references
AAAAI/ACAAI Atopic Dermatitis Guideline Panel 2024
-
- Chu DK, Schneider L, Asiniwasis RN, Boguniewicz M, De Benedetto A, et al, AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel. Atopic dermatitis (eczema) guidelines: 2023 american academy of allergy, asthma and immunology/american college of allergy, asthma and immunology joint task force on practice parameters: GRADE- and institute of medicine-based recommendations. Annals of Allergy, Asthma and Immunology 2024;132(3):274-312. [DOI: 10.1016/j.anai.2023.11.009] - DOI - PubMed
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