Interventions for basal cell carcinoma of the skin
- PMID: 33202063
- PMCID: PMC8164471
- DOI: 10.1002/14651858.CD003412.pub3
Interventions for basal cell carcinoma of the skin
Abstract
Background: Basal cell carcinoma (BCC) is the commonest cancer affecting white-skinned individuals, and worldwide incidence is increasing. Although rarely fatal, BCC is associated with significant morbidity and costs. First-line treatment is usually surgical excision, but alternatives are available. New published studies and the development of non-surgical treatments meant an update of our Cochrane Review (first published in 2003, and previously updated in 2007) was timely.
Objectives: To assess the effects of interventions for BCC in immunocompetent adults.
Search methods: We updated our searches of the following databases to November 2019: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and LILACS.
Selection criteria: Randomised controlled trials (RCTs) of interventions for BCC in immunocompetent adults with histologically-proven, primary BCC. Eligible comparators were placebo, active treatment, other treatments, or no treatment.
Data collection and analysis: We used standard methodological procedures expected by Cochrane. Primary outcome measures were recurrence at three years and five years (measured clinically) (we included recurrence data outside of these time points if there was no measurement at three or five years) and participant- and observer-rated good/excellent cosmetic outcome. Secondary outcomes included pain during and after treatment, early treatment failure within six months, and adverse effects (AEs). We used GRADE to assess evidence certainty for each outcome.
Main results: We included 52 RCTs (26 new) involving 6690 participants (median 89) in this update. All studies recruited from secondary care outpatient clinics. More males than females were included. Study duration ranged from six weeks to 10 years (average 13 months). Most studies (48/52) included only low-risk BCC (superficial (sBCC) and nodular (nBCC) histological subtypes). The majority of studies were at low or unclear risk of bias for most domains. Twenty-two studies were industry-funded: commercial sponsors conducted most of the studies assessing imiquimod, and just under half of the photodynamic therapy (PDT) studies. Overall, surgical interventions have the lowest recurrence rates. For high-risk facial BCC (high-risk histological subtype or located in the facial 'H-zone' or both), there may be slightly fewer recurrences with Mohs micrographic surgery (MMS) compared to surgical excision (SE) at three years (1.9% versus 2.9%, respectively) (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.16 to 2.64; 1 study, 331 participants; low-certainty evidence) and at five years (3.2% versus 5.2%, respectively) (RR 0.61, 95% CI 0.18 to 2.04; 1 study, 259 participants; low-certainty evidence). However, the 95% CI also includes the possibility of increased risk of recurrence and no difference between treatments. There may be little to no difference regarding improvement of cosmetic outcomes between MMS and SE, judged by participants and observers 18 months post-operatively (one study; low-certainty evidence); however, no raw data were available for this outcome. When comparing imiquimod and SE for nBCC or sBCC at low-risk sites, imiquimod probably results in more recurrences than SE at three years (16.4% versus 1.6%, respectively) (RR 10.30, 95% CI 3.22 to 32.94; 1 study, 401 participants; moderate-certainty evidence) and five years (17.5% versus 2.3%, respectively) (RR 7.73, 95% CI 2.81 to 21.3; 1 study, 383 participants; moderate-certainty evidence). There may be little to no difference in the number of participant-rated good/excellent cosmetic outcomes (RR 1.00, 95% CI 0.94 to 1.06; 1 study, 326 participants; low-certainty evidence). However, imiquimod may result in greater numbers of good/excellent cosmetic outcomes compared to SE when observer-rated (60.6% versus 35.6%, respectively) (RR 1.70, 95% CI 1.35 to 2.15; 1 study, 344 participants; low-certainty evidence). Both cosmetic outcomes were measured at three years. Based on one study of 347 participants with high- and low-risk primary BCC of the face, radiotherapy may result in more recurrences compared to SE under frozen section margin control at three years (5.2% versus 0%, respectively) (RR 19.11, 95% CI 1.12 to 325.78; low-certainty evidence) and at four years (6.4% versus 0.6%, respectively) (RR 11.06, 95% CI 1.44 to 84.77; low-certainty evidence). Radiotherapy probably results in a smaller number of good participant- (RR 0.76, 95% CI 0.63 to 0.91; 50.3% versus 66.1%, respectively) or observer-rated (RR 0.48, 95% CI 0.37 to 0.62; 28.9% versus 60.3%, respectively) good/excellent cosmetic outcomes compared to SE, when measured at four years, where dyspigmentation and telangiectasia can occur (both moderate-certainty evidence). Methyl-aminolevulinate (MAL)-PDT may result in more recurrences compared to SE at three years (36.4% versus 0%, respectively) (RR 26.47, 95% CI 1.63 to 429.92; 1 study; 68 participants with low-risk nBCC in the head and neck area; low-certainty evidence). There were no useable data for measurement at five years. MAL-PDT probably results in greater numbers of participant- (RR 1.18, 95% CI 1.09 to 1.27; 97.3% versus 82.5%) or observer-rated (RR 1.87, 95% CI 1.54 to 2.26; 87.1% versus 46.6%) good/excellent cosmetic outcomes at one year compared to SE (2 studies, 309 participants with low-risk nBCC and sBCC; moderate-certainty evidence). Based on moderate-certainty evidence (single low-risk sBCC), imiquimod probably results in fewer recurrences at three years compared to MAL-PDT (22.8% versus 51.6%, respectively) (RR 0.44, 95% CI 0.32 to 0.62; 277 participants) and five years (28.6% versus 68.6%, respectively) (RR 0.42, 95% CI 0.31 to 0.57; 228 participants). There is probably little to no difference in numbers of observer-rated good/excellent cosmetic outcomes at one year (RR 0.98, 95% CI 0.84 to 1.16; 370 participants). Participant-rated cosmetic outcomes were not measured for this comparison. AEs with surgical interventions include wound infections, graft necrosis and post-operative bleeding. Local AEs such as itching, weeping, pain and redness occur frequently with non-surgical interventions. Treatment-related AEs resulting in study modification or withdrawal occurred with imiquimod and MAL-PDT.
Authors' conclusions: Surgical interventions have the lowest recurrence rates, and there may be slightly fewer recurrences with MMS over SE for high-risk facial primary BCC (low-certainty evidence). Non-surgical treatments, when used for low-risk BCC, are less effective than surgical treatments, but recurrence rates are acceptable and cosmetic outcomes are probably superior. Of the non-surgical treatments, imiquimod has the best evidence to support its efficacy. Overall, evidence certainty was low to moderate. Priorities for future research include core outcome measures and studies with longer-term follow-up.
Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
Jason Thomson: none known Sarah Hogan: none known Jo Leonardi‐Bee: none known Hywel C Williams and Fiona J Bath‐Hextall were involved in the SINS trial that compared topical imiquimod versus surgery and is a trial that is included in this review (Bath‐Hextall 2014). The trial was funded by Cancer Research UK, a UK cancer charity. They were not involved in extracting data from the trial nor commenting on the evidence from this trial. Neither the charity, Fiona J Bath‐Hextall or Hywel Williams have any links with industry.
Figures
Update of
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Interventions for basal cell carcinoma of the skin.Cochrane Database Syst Rev. 2007 Jan 24;(1):CD003412. doi: 10.1002/14651858.CD003412.pub2. Cochrane Database Syst Rev. 2007. Update in: Cochrane Database Syst Rev. 2020 Nov 17;11:CD003412. doi: 10.1002/14651858.CD003412.pub3. PMID: 17253489 Updated.
Comment in
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From the Cochrane Library: Interventions for basal cell carcinoma of the skin.J Am Acad Dermatol. 2021 Dec;85(6):e417-e418. doi: 10.1016/j.jaad.2021.08.046. Epub 2021 Sep 7. J Am Acad Dermatol. 2021. PMID: 34499991 No abstract available.
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Basal Cell Carcinoma: Comparison of Surgical and Nonsurgical Interventions.Am Fam Physician. 2021 Nov 1;104(5):459-460. Am Fam Physician. 2021. PMID: 34783489 No abstract available.
References
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- Schumack S, Robinson J, Kossard S, Golitz L, Greenway H, Schroeter, A et al. Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma. Archives of Dermatology 2002;138(9):1165-71. [CENTRAL: CN-00398024] - PubMed
Siller 2010 {published data only}
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- Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM. PEP005 (Ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomised phase IIa trial. Australasian Journal of Dermatology 2010;51(2):99-105. [CENTRAL: CN-00771587] - PubMed
Smeets 2004 {published data only}
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- Essers BA, Dirksen CD, Nieman FH, Smeets NW, Krekels GA, Prins MH, et al. Cost-effectiveness of Mohs micrographic surgery vs surgical excision for basal cell carcinoma of the face. Archives of Dermatology 2006;142(2):187-94. [CENTRAL: CN-00555278] - PubMed
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- Mosterd K, Krekels GA, Nieman FH, Ostertag JU, Essers BA, Dirksen CD, et al. Surgical excision versus Mohs' micrographic surgery for primary and recurrent basal-cell carcinoma of the face: a prospective randomised controlled trial with 5-years' follow-up. Lancet Oncology 2008;9(12):1149-56. [CENTRAL: CN-00665334] - PubMed
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- Smeets NW, Krekels GA, Ostertag JU, Essers BA, Dirksen CD, Nieman FH, et al. Surgical excision vs Mohs' micrographic surgery for basal-cell carcinoma of the face: randomised controlled trial. Lancet 2004;364(9447):1766-72. [CENTRAL: CN-00492695] - PubMed
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- Van Loo E, Mosterd K, Krekels GA, Roozeboom MH, Ostertag JU, Dirksen CD, et al. Surgical excision versus Mohs' micrographic surgery for basal cell carcinoma of the face: A randomised clinical trial with 10 year follow-up. European Journal of Cancer 2014;50(17):3011-20. [CENTRAL: CN-01043314] - PubMed
Soler 2000 {published data only}
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- Soler AM, Angell-Petersen E, Warloe T, Tausjo J, Steen HB, Moan J, et al. Photodynamic therapy of superficial basal cell carcinoma with 5-aminolevulinic acid with dimethylsulfoxide and ethylendiaminetetraacetic acid: A comparison of two light sources. Photochemistry and Photobiology 2000;71(6):724-9. [CENTRAL: CN-00297518] - PubMed
Spelman 2014 {published data only}
-
- Rosen R, Freeman M, Zibert JR, Katsamas J, Knudsen KM, Spelman L. Ingenol mebutate 0.05% gel under occlusion is efficacious in treating superficial basal cell carcinoma. British Journal of Dermatology 2014;171(Suppl 4):50. [CENTRAL: CN-01057057]
Sterry 2002a {published data only}
-
- Sterry W, Bichel J, Andres K, Ginkel AM. Imiquimod 5% cream for 6 weeks with occlusion treating superficial BCC. In: 8th World Congress on cancers of the skin, Zurich, Switzerland. 2001:61. [CENTRAL: CN-00478768]
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- Sterry W, Bichel J, Ding L, Ginkel AM. Imiquimod 5% cream for 6 weeks with occlusion treating nodular BCC. In: 8th World Congress on Cancer of the skin, Zurich, Switzerland. 2001.
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- Sterry W, Ruzicka T, Herrera E, Takwale A, Bichel J, Andres K, et al. Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma: randomized studies comparing low-frequency dosing with and without occlusion. British Journal of Dermatology 2002;147(6):1227-36. [CENTRAL: CN-00411766] [PMID: ] - PubMed
Sterry 2002b {published data only}
-
- Sterry W, Bichel J, Andres K, Ginkel AM. Imiquimod 5% cream for 6 weeks with occlusion treating superficial BCC. 8th World Congress on cancers of the skin, Zurich, Switzerland 2001;-(-):p61. [CENTRAL: CN-00478768]
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- Sterry W, Bichel J, Ding L, Ginkel AM. Imiquimod 5% cream for 6 weeks with occlusion treating nodular BCC. In: 8th World Congress on Cancer of the skin, Zurich, Switzerland. 2001.
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- Sterry W, Ruzicka T, Herrera E, Takwale A, Bichel J, Andres K, et al. Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma: randomized studies comparing low-frequency dosing with and without occlusion. British Journal of Dermatology 2002;147(6):1227-36. [CENTRAL: CN-00411766] - PubMed
Szeimies 2008 {published data only}
-
- Szeimies RM, Ibbotson S, Murrell DF, Rubel D, Frambach Y, De Berker D, et al. A clinical study comparing methyl aminolevulinate photodynamic therapy and surgery in small superficial basal cell carcinoma (8-20mm), with a 12-month follow-up. Journal of the European Academy of Dermatology and Venereology 2008;22(11):1302-11. [CENTRAL: CN-00668334] - PubMed
Tran 2012 {published data only}
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- Tran HT, Lee RA, Oganesyan G, Jiang SB. Single treatment of non-melanoma skin cancers using a pulsed-dye laser with stacked pulses. Lasers in Surgery and Medicine 2012;44(6):459-67. [CENTRAL: CN-00969795] - PubMed
Wang 2001 {published data only}
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- Wang I, Bendsoe N, Klinteberg CA, Enejder AM, Andersson‐Engels S, Svanberg S, et al. Photodynamic therapy vs. cryosurgery of basal cell carcinomas: results of a phase III clinical trial. British Journal of Dermatology 2000;144(4):832-40. [CENTRAL: CN-00326537] - PubMed
References to studies excluded from this review
Al‐Niaimi 2015 {published data only}
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- Al-Niaimi F, Sheth N, Kurwa HA, Mallipeddi R. Photodynamic therapy followed by Mohs micrographic surgery compared to mohs micrographic surgery alone for the treatment of basal cell carcinoma: results of a pilot single-blinded randomised controlled trial. Journal of Cutaneous and Aesthetic Surgery 2015;8(2):88-91. [CENTRAL: CN-02012011] - PMC - PubMed
Arits 2014 {published data only}
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- Arits AH, Spoorenberg E, Mosterd K, Nelemans P, Kelleners‐Smeets NW, Essers BA. Cost-effectiveness of topical imiquimod and fluorouracil vs. photodynamic therapy for treatment of superficial basal-cell carcinoma. British Journal of Dermatology 2014;171(6):1501-07. [CENTRAL: CN-01117058] - PubMed
Berroeta 2007 {published data only}
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- Berroeta L, Clark C, Dawe RS, Ibbotson SH, Fleming CJ. A randomized study of minimal curettage followed by topical photodynamic therapy compared with surgical excision for low-risk nodular basal cell carcinoma. British Journal of Dermatology 2007;157(2):401-3. [CENTRAL: CN-00610206] - PubMed
Butler 2009 {published data only}
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- Butler DF, Parekh PK, Lenis A. Imiquimod 5% cream as adjunctive therapy for primary solitary, nodular basal cell carcinomas before Mohs Micrographic Surgery: a randomized, double blind vehicle-controlled study. Dermatologic Surgery 2009;35(1):24-9. [CENTRAL: CN-00669203] - PubMed
Čarija 2016 {published data only}
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- Čarija A, Puizina-Ivić N, Vuković D, Mirić Kovačević L, Čapkun V. Single treatment of low-risk basal cell carcinomas with pulsed dye laser-mediated photodynamic therapy (PDL-PDT) compared with photodynamic therapy (PDT): a controlled, investigator-blinded, intra-individual prospective study. Photodiagnosis and Photodynamic Therapy 2016;16:60-5. [CENTRAL: CN-01342603] - PubMed
Cho 2013 {published data only}
de Haas 2006 {published data only}
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- Haas ER, Kruijt B, Sterenborg HJ, Neumann HM, Robinson DJ. Fractionated illumination significantly improves the response of superficial basal cell carcinoma to aminolevulinic acid photodynamic therapy. Journal of Investigative Dermatology 2006;126(12):2679-86. [CENTRAL: CN-00571166] - PubMed
Dessinioti 2014 {published data only}
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- Dessinioti C, Plaka M, Stratigos AJ. Vismodegib for the treatment of basal cell carcinoma: results and implications of the ERIVANCE BCC trial. Future Oncology 2014;10(6):927-36. - PubMed
EudraCT 2013‐000092‐33 {unpublished data only}
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- EduraCT 2013-000092-33. Enhanced efficacy of photodynamic therapy in combination with 5% imiquimod -a randomised, prospective, observer-blinded study in patients with non melanoma skin cancer. www.clinicaltrialsregister.eu/ctr-search/search?query=2013-000092-33 (first received 19 September 2013). [2013-000092-33]
Genouw 2018 {published data only}
-
- Genouw E, Verheire B, Ongenae K, De Schepper S, Creytens D, Verhaeghe E, et al. Laser-assisted photodynamic therapy for superficial basal cell carcinoma and Bowen's disease: a randomized intrapatient comparison between a continuous and a fractional ablative CO2 laser mode. Journal of the European Academy of Dermatology and Venereology : JEADV 2018;32(11):1897-905. [PMID: ] - PubMed
Groselj 2018 {published data only}
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- Groselj A, Bosnjak M, Strojan P, Krzan M, Cemazar M, Sersa G. Efficiency of electrochemotherapy with reduced bleomycin dose in the treatment of nonmelanoma head and neck skin cancer: Preliminary results. Head & Neck 2018;40(1):120-5. [CENTRAL: CN-01475261] - PubMed
Huang 2004 {published data only}
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- Huang CC, Boyce S, Northington M, Desmond R, Soong S-J. Randomised, controlled surgical trial of preoperative tumour curettage of basal cell carcinoma in Mohs micrographic surgery. Journal of the American Academy of Dermatology 2004;51(4):585-91. [CENTRAL: CN-00497417] - PubMed
Ibbotson 2018 {published data only}
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- Ibbotson S, Dawe R, Moseley H, Samuel I, Ferguson J. A randomized, controlled trial of portable compared with conventional photodynamic therapy for superficial nonmelanoma skin cancer. British Journal of Dermatology 2018;179(Suppl 1):100. [CENTRAL: CN-01620045]
Lippert 2013 {published data only}
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- Lippert J, Šmucler R, Vlk M. Fractional carbon dioxide laser improves nodular basal cell carcinoma treatment with photodynamic therapy with methyl 5-aminolevulinate. Dermatologic Surgery 2013;39(8):1202-8. [CENTRAL: CN-02012012] [PMID: ] - PubMed
Lu 2017 {published data only}
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- Lu W, Feng W, Tang Y, Tao X, Pan L. Study of ALA and small dosage of HPD photodynamic therapy (HPD-PDT) in treatment of skin cancer. Biomedical Research (India) 2017;28(14):6476-9. [CENTRAL: CN-01417427]
Lui 2004 {published data only}
-
- Lui H, Hobbs L, Tope WD, Lee PK, Elmets C, Provost N, et al. Photodynamic therapy of multiple nonmelanoma skin cancers with verteporfin and red light-emitting diodes. Archives of Dermatology 2004;140(1):26-32. [CENTRAL: CN-00460095] - PubMed
Migden 2015 {published data only}
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- Migden MR, Guminski A, Gutzmer R, Dirix L, Lewis KD, Combemale P, et al. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncology 2015;16(6):716-28. [CENTRAL: CN-01109355] - PubMed
NCT01033019 {unpublished data only}
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- NCT01033019. To evaluate the safety, local tolerability, PK and PD of LDE225 on sporadic superficial and nodular skin basal cell carcinomas (sBCC). clinicaltrials.gov/ct2/show/NCT01033019 (first received 16 December 2009).
Nguyen 2018 {published data only}
-
- Nguyen KP, Knuiman GJ, Blokx WA, Hoogedoorn L, Smits T, Gerritsen MJ. Is a single day patient friendly methyl aminolevulinate photodynamic therapy illumination scheme for superficial basal cell carcinoma feasible? A randomized multicenter pilot trial. Journal of Dermatological Treatment 2019;30(2):194-9. [CENTRAL: CN-01930357] [DOI: 10.1080/09546634.2018.1484558] - DOI - PubMed
Quirk 2010 {published data only}
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- Quirk C, Gebauer K, De'Ambrosis B, Slade HB, Meng TC. Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study. Cutis 2010;85(6):318-24. [PMID: ] - PubMed
Radiotis 2014 {published data only}
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- Radiotis G, Roberts N, Czajkowska Z, Khanna M, Korner A. Nonmelanoma skin cancer: disease-specific quality-of-life concerns and distress. Oncology Nursing Forum 2014;41(1):57-65. [PMID: ] - PubMed
Schleier 2007 {published data only}
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- Schleier P, Berndt A, Kolossa S, Zenk W, Hyckel P, Schultze-Mosgau S. Comparison of aminolevulinic acid (ALA)-thermogel-PSDT with methyl-ALA-thermogel-PDT in basal cell carcinoma. Photodiagnosis and Photodynamic Therapy 2007;4(3):197-201. [CENTRAL: CN-01951238] - PubMed
Sekulic 2012 {published data only}
Spencer 2006 {published data only}
-
- Spencer JM. Pilot study of Imiquimod 5% cream as adjunctive therapy to curettage and electrodesiccation for nodular and basal cell carcinoma. Dermatologic Surgery 2006;32(1):63-9. [CENTRAL: CN-00554023] [PMID: ] - PubMed
Tang 2012 {published data only}
van der Geer 2012 {published data only}
-
- Van der Geer S, Martens J, Van Roij J, Brand E, Ostertag JU, Verhaegh ME, et al. Imiquimod 5% cream as pre-treatment of Mohs Micrographic Surgery for nodular basal cell carcinoma in the face, a prospective randomized controlled study. British Journal of Dermatology 2012;167(1):110-5. [CENTRAL: CN-00856436] - PubMed
Vijlder 2012 {published data only}
-
- Vijlder HC, Sterenborg HJ, Neumann HA, Robinson DJ, Haas ER. Light fractionation significantly improves the response of superficial basal cell carcinoma to aminolaevulinic acid photodynamic therapy: five-year follow-up of a randomized, prospective trial. Acta Dermato-Venereologica 2012;92(6):641-7. [CENTRAL: CN-00878966] - PubMed
Wettstein 2013 {published data only}
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- Wettstein R, Erba P, Itin P, Schaefer DJ, Kalbermatten DF. Treatment of basal cell carcinoma with surgical excision and perilesional interferon-alpha. Journal of Plastic, Reconstructive and Aesthetic Surgery 2013;66(7):912-6. [CENTRAL: CN-00964441] - PubMed
Zane 2017 {published data only}
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- Zane C, Facchinetti E, Arisi M, Ortel B, Calzavara-Pinton P. Pulsed CO2 laser ablation of superficial basal cell of limbs and trunk: a comparative randomized clinical trial with cryotherapy and surgical ablation. Dermatologic Surgery 2017;43(7):920-7. [CENTRAL: CN-01401171] - PubMed
References to studies awaiting assessment
Bunker 2000 {unpublished data only}
-
- Bunker C. 5 Fluoracil/Adrenaline injectable gel in basal cell carcinoma. National Research Register.
IRCT 2017 030732933N1 {unpublished data only}
-
- IRCT2017030732933N1. A comparison between efficacy and safety of 585-nanometer pulsed dye laser alone and with cryotherapy in treating superficial basal cell carcinoma. en.irct.ir/trial/25544 (first received 21 May 2017).
ISRCTN 92678315 {unpublished data only}
-
- ISRCTN 92678315. Effect of penetration enhancers in topical photodynamic therapy [Comparison of 20% Aminolaevulinic acid (ALA) versus 20% ALA 2% dimethyl sulphoxide (DMSO) 2% ethylene diamine tetraacetic acid (EDTA) in topical photodynamic therapy]. doi.org/10.1186/ISRCTN92678315 (first received 8 April 2002).
Kang 2018 {published data only}
-
- Kang K, Han M, Cong M, Chen S, Zhang X, Zhang J. The effects of Ella light power combined with imiquimod cream on basal cell carcinoma. Anti-Tumor Pharmacy 2018;8(2):258-62. [en.cnki.com.cn/Article_en/CJFDTotal-LIYX201802033.htm]
Ma 2018 {published data only}
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- Ma X, Li L, Ma X, Yang J, He Y. Effect of adriamycin combined with cisplatin on basal cell carcinoma and the level of vascular endothelial growth factor in patients. Anti-tumor Pharmacy 2018;6:951-4.
RPCEC00000147 {unpublished data only}
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- RPCEC00000147. Efficacy study, randomized, controlled, with CIGB-128-A injected perilesional in basal cell carcinoma in different treatment schedules (InCarbacel-V study). registroclinico.sld.cu/en/trials/RPCEC00000147-En (first received 1 February 2013).
References to ongoing studies
EudraCT 2016‐002255‐25 {unpublished data only}
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- EudraCT 2016-002255-25. Electrochemotherapy compared with radiotherapy for the treatment of basal cell carcinoma. www.clinicaltrialsregister.eu/ctr-search/search?query=2016-002255-25 (first received 12 September 2016). [2016-002255-25]
NCT02242929 {unpublished data only}
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NCT03573401 {unpublished data only}
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- NCT03573401. A randomized, double blind, vehicle-controlled multicenter phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the treatment of superficial basal cell carcinoma (sBCC) with photodynamic therapy (PDT). clinicaltrials.gov/ct2/show/NCT03573401 (first received 29 June 2018).
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References to other published versions of this review
Bath‐Hextall 2003
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