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. 2020 Sep;13(9):15-20.
Epub 2020 Sep 1.

Lidose-Isotretinoin Administered Without Food Improves Quality of Life in Patients With Severe Recalcitrant Nodular Acne: An Open-Label, Single-Arm, Phase IV Study

Andrea L Zaenglein  1   2   3   4 , Jeanett Segal  1   2   3   4 , Charles Darby  1   2   3   4 , James Q Del Rosso  1   2   3   4
Affiliations

Lidose-Isotretinoin Administered Without Food Improves Quality of Life in Patients With Severe Recalcitrant Nodular Acne: An Open-Label, Single-Arm, Phase IV Study

Andrea L Zaenglein et al. J Clin Aesthet Dermatol. 2020 Sep.

Abstract

OBJECTIVE: We sought to assess the impact of Lidose-isotretinoin taken without food on patient quality of life (QoL) at baseline, monthly intervals, and end of study in patients with severe recalcitrant nodular acne. DESIGN: In this open-label, single-arm, multicenter study, 197 patients took twice-daily Lidose-isotretinoin without food for 20 weeks (120-150mg/kg cumulative dosage). Patient visits occurred at Weeks 2, 4, 8, 12, 16, and 20. At baseline and Weeks 4, 8, 12, 16, and 20, patients underwent QoL and acne severity assessments and lesion counts. SETTING: Participants were enrolled from 21 sites across the United States. PARTICIPANTS: Eligible participants were 12 to 45 years of age, weighing 40 to 110kg, and with e;5 facial nodules and no prior exposure to systemic retinoids, including isotretinoin. Female participants were nonpregnant and nonlactating. MEASUREMENTS: An acne-specific QoL questionnaire (Acne-QoL) was used to assess QoL. Efficacy endpoints were lesion counts and Investigator Global Assessment (IGA) of acne severity. Safety assessments included reported adverse events. RESULTS: Lidose-isotretinoin taken without food significantly improved mean (standard deviation) overall Acne-QoL score from baseline (61.6 [28.7]) to end of treatment (101.8 [16.9]; P<0.0001). Improvements were shown in both male and female patients. Significant improvements in patient QoL (overall and by questionnaire domain), lesion counts, and IGA scores were observed as early as Week 4 and continued to improve throughout treatment. CONCLUSION: Twice-daily Lidose-isotretinoin taken without food for 20 weeks significantly improved patient QoL from Week 4.

Keywords: Acne; Investigator Global Assessment; Lidose-isotretinoin; isotretinoin; lesions; quality of life.

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Conflict of interest statement

FUNDING:The study was funded by Sun Pharmaceutical Industries, Inc., Princeton, New Jersey. DISCLOSURES:ALZ has received grants from, and/or served as a consultant/advisor and/or investigator for Abbvie, Allergan, Incyte, Innovaderm, Ortho Dermatologics, Pfizer, and Ranbaxy/Sun Pharmaceuticals. JS is an employee of Sun Pharmaceutical Industries, Inc. CD is a contracted consultant to Sun Pharma Advanced Research Company Ltd. JQD has received grants from, and/or served as a consultant/advisor, investigator, and/or speaker for Abbvie, Aclaris, Almirall, Athenex, BioPharmX, Botanix, Cassiopeia, Celgene, Cutanea (Biofrontera), Dermira, Encore, EPI Health, Ferndale, Foamix, Galderma, Genentech, LaRoche Posay, Leo Pharma, Menlo Therapeutics, Novan, Ortho Dermatologics, Pfizer, Promius, Regeneron, Sanofi/Genzyme, Sonoma (Intraderm), Sol Gel, Sun Pharmaceuticals, and Verrica.

Figures

FIGURE 1.
FIGURE 1.
Patient disposition. aOne patient discontinued treatment because of an AE (depression) on Day 112. The patient was observed until AE resolution on Day 191, but was not included in the PP population; bThree because of pharmacy access issues and one because of a move away from study site. AE: adverse event; ATP: active treatment period; ITT: intention-to-treat; PP: per-protocol
FIGURE 2.
FIGURE 2.
Mean overall Acne-QoL score over time during the ATP (PP population). Error bars represent standard deviation. Acne-QoL: acne-specific QoL questionnaire; ATP: active treatment phase; EOT: end of treatment; PP: per-protocol; QoL: quality of life; SD: standard deviation
FIGURE 3.
FIGURE 3.
Mean overall Acne-QoL score over time by sex during the ATP (PP population). Error bars represent standard deviation. Acne-QoL: acne-specific QoL questionnaire; ATP: active treatment phase; EOT: end of treatment; PP: per-protocol; QoL: quality of life; SD: standard deviation
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References

    1. Ingram J, Grindlay D, Williams H. Management of acne vulgaris: an evidence-based update. Clin Exp Dermatol. 2010;35(4):351–354. - PubMed
    1. AAD site. Dermatologist evaluates latest isotretinoin developments for treatment of severe acne. 2014. https://www.aad.org/media/news-releases/dermatologist-evaluates-latest-i... Accessed 11 Aug 2020.
    1. Merritt B, Burkhart C, Morrell D. Use of isotretinoin for acne vulgaris. Pediatr Ann. 2009;38(6):311–320. - PubMed
    1. Marron S, Tomas-Aragones L, Boira S. Anxiety, depression, quality of life and patient satisfactions in acne patients treated with oral isotretinoin. Acta Derm Venereol. 2013;93:701–706. - PubMed
    1. ACCUTANE® (isotretinoin) capsules. Prescribing information. Roche Laboratories Inc. 2008.

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