Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6 Month Randomized, Vehicle Controlled Trial Using Intra Individual Comparison
BackgroundVery few clinical trials have investigated the effect of topical acne treatment on scarring.ObjectivesOur objective was to evaluate the efficacy of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) in atrophic acne scar formation in patients with acne.MethodsIn this multicenter, randomized, investigator blinded, vehicle controlled study, subjects with moderate or severe facial acne (Investigator's Global Assessment [IGA] score 3 or 4; 25 inflammatory lesions; ten or more atrophic acne scars) applied A0.3/BPO2.5 or vehicle daily per half face for 24 weeks. Subjects with acne requiring systemic treatment were excluded. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA) acne lesion count, IGA, skin roughness and skin texture, subject self assessment of clinical acne related scars and satisfaction questionnaire, tolerability, and safety.ResultsIncluded subjects (n 67) had mainly moderate acne (92.5% IGA 3) mean scores at baseline were approximately 40 acne lesions and 12 scars per half face. By week 24, the change from baseline in total scar count was 15.5% for A0.3/BPO2.5 versus 14.4% for vehicle (approximately 30% difference) with a mean of 9.5 scars versus 13.3 per half face, respectively (p 0.0001) For SGA at week 24, a total of 32.9% with A0.3/BPO2.5 versus 16.4% with vehicle (p 0.01) were clear/almost clear. Inflammatory acne lesions decreased by 86.7% for A0.3/BPO2.5 versus 57.9% for vehicle (p 0.0001) and 64.2 versus 19.4% of subjects, respectively, were IGA clear/almost clear (p 0.0001) at week 24. Treatment related AEs were reported by 20.9% for A0.3/BPO2.5 versus 9% for vehicle side, most commonly skin irritation (14.9 vs. 6% respectively).ConclusionsTopical A0.3/BPO2.5 prevented and reduced atrophic scar formation. Scar count increased with vehicle 14.4% but decreased with A0.3/BPO2.5 15.5% over 24 weeks.Trial registryClinicalTrials.gov identifier NCT02735421.
American Journal of Clinical Dermatology