PARIS – Treatment with the fixed combination in a multicenter, randomized trial, Brigitte Dreno, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“To my knowledge, this is the first time that we have seen a topical therapy showing a reduction in atrophic acne scars,” said, professor and chair of the department of dermatology at Nantes (France) University Hospital.
She reported on 67 adolescents and adults with mainly moderate facial acne randomized to treat half their face with adapalene 0.3%/benzoyl peroxide 2.5% gel (Epiduo Forte) and the other half with the product’s vehicle daily for 6 months. Investigators were blinded as to which side was which. At baseline, patients averaged 40 acne lesions and 12 scars per half face.
The primary efficacy endpoint was the atrophic acne scar count per half face at week 24. At that point, the mean total was 9.5 scars on the active treatment side, compared with 13.3 on the control side. This translated to a statistically significant and clinically meaningful 15.5% decrease in scars with active treatment versus a 14.4% increase with vehicle. The between-side difference achieved statistical significance at week 1 and remained so at all follow-up visits through week 24.
By Scar Global Assessment at week 24, 32.9% of half faces treated with the combination product were rated clear or almost clear, compared with 16.4% with vehicle.
At 24 weeks, 24.1% of participants reported having moderately or very visible holes or indents on the active treatment side of their face, compared with 51.8% on the control side. The number of inflammatory acne lesions fell by 86.7% with the active treatment and 57.9% with vehicle over the course of 24 weeks. Again, the difference became statistically significant starting at week 1. By the Investigator’s Global Assessment at week 24, 64.2% of adapalene/benzoyl peroxide gel–treated faces were rated clear or almost clear, as were 19.4% with vehicle. In addition, 32% of patients reported a marked improvement in skin texture on their active treatment side at 24 weeks, as did 14% on the control side.
The salutary effect on acne scars documented with a topical therapy in this study represents a real advance in clinical care.
“Facial acne scars are a very important and difficult problem for our patients and also for dermatologists,” Dr. Dreno observed, adding that the evidence base for procedural interventions for acne scars, such as dermabrasion and laser resurfacing, is not top quality.
Not surprisingly with a topical retinoid, skin irritation was the most common treatment-emergent adverse event, reported by 14.9% of patients on their active treatment side and 6% with vehicle. This side effect was typically mild and resolved within the first 2-3 weeks.
The improvement in preexisting acne scars documented in this trial was probably caused by drug-induced remodeling of the dermal matrix, according to Dr. Dreno.
The study was funded by Galderma. Dr. Dreno reported receiving research grants from and/or serving as a consultant to Galderma, Bioderma, Pierre Fabre, and La Roche–Posay.