Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study
June 2019 | Volume 18 | Issue 6 | Original Article | 514 | Copyright © June 2019
Janet DuBois MD,a Gavin Chun Wei Ong MD,b Gitanjali Petkar MBBS, DDV,c, Luiz Mauricio Costa Almeida MD,d Rajeev Chavda MD,e Nabil Kerrouche MSc,f and Andrew F. Alexis MD MPHg
aDermResearch, Inc., Austin, TX bCentre International De Developpement Pharmaceutique PTE Ltd (CIDP), Biopolis, Singapore cCentre International De Developpement Pharmaceutique Ltd (CIDP), Bio Park, Mauritius dFaculdade de Ciências Médicas de Minas Gerais, Belo Horizonte, Brazil eMedical Evidence, Galderma S.A., Vevey, Switzerland fGalderma R&D, Sophia Antipolis, France gDepartment of Dermatology, Mount Sinai St. Luke's and Mount Sinai West; Icahn School of Medicine at Mount Sinai; Skin of Color Center, New York, NY
Abstract
Background: Patients with skin of color (SOC) and Fitzpatrick skin types (FST) IV–VI frequently develop acne.
Objective: Evaluate subject-reported outcomes after treatment with adapalene 0.3%/ benzoyl peroxide 2.5% gel (0.3% A/BPO) in subjects with SOC and moderate to severe acne vulgaris.
Methods: This was an open-label interventional study conducted in 3 countries (Mauritius, Singapore, and USA) in subjects of Asian, Latin-American, or black/African-American ethnicity, with an Investigator’s Global Assessment (IGA) of moderate or severe facial acne (enrollment 2:1), and FST IV to VI. For 16 weeks, subjects applied 0.3% A/BPO (once daily) and utilized a skin care regimen (oil control foam wash and oil control moisturizer SPF30). Assessments included quality of life (QoL) and subject questionnaires, IGA, Investigator’s Global Assessment of Improvement (GAI), postinflammatory hyperpigmentation (PIH; if present at baseline), and safety.
Results: Fifty subjects were enrolled: 20 Asians, 17 black/African-Americans, and 13 Latin-Americans. Most had FST IV (74%) or V (22%), with moderate (70%; IGA 3) or severe (30%; IGA 4) acne. At week 16, 77% of subjects were satisfied or very satisfied with treatment, 56% of subjects had an IGA of 0 or 1 (clear/almost clear), and 87% had a good to excellent improvement in GAI. QoL improved throughout the study for all subjects; subject selection of “no effect at all” of acne on QoL increased from 16% of subjects at baseline to 55% at week 16. Of those with baseline PIH (60%), all were rated very mild to moderate. By week 16, the majority (75%) had no or very mild PIH, and the mean decrease in PIH was 27%. There were no adverse events leading to study discontinuation.
Conclusion: Patients with SOC and moderate or severe facial acne reported high satisfaction with 0.3% A/BPO treatment and experienced good tolerability, improved QoL, treatment efficacy, and improvement in PIH.
Clinicaltrials.gov number: NCT02932267
J Drugs Dermatol. 2019;18(6):514-520.
INTRODUCTION
Acne vulgaris is a common chronic disorder, constituting the eighth most prevalent disease with an estimated 9% global prevalence.1 Acne negatively impacts quality of life, whereas effective treatment may improve it.2 Acne is present among people with all Fitzpatrick skin types (FST) and ethnicities.3 Patients, including those with darker skin tones typically known as skin of color (SOC) with FST IV–VI, frequently consult dermatologists for acne. For example, in a New York hospital-based dermatology practice, acne was the most common reason for visits in both African-American and Caucasian patients (28% and 21%, respectively).4 A survey of Brazilian dermatologists revealed that acne was the most frequent cause for consultation (8%), with similar rates between white and non-white patients.5 Moreover, in Mauritius, a tropical country which is inhabited by a multi-ethnic population of Indian, Asian, Caucasian, and African origin, a hospital-based study among young adults revealed acne to be the most common skin pathology (13%).6
In a photograph-based study of 2895 women of 4 ethnicities, acne was more prevalent in African-American and Hispanic women (37% and 32%, respectively) than in Continental In-
