Long-Term Effectiveness and Safety of Up to 48 Weeks’ Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne
Scarring is a frequent consequence of acne.
Our objective was to evaluate the effect of up to 48 weeks’ treatment with adapalene 0.3%/benzoyl peroxide 2.5% (A0.3/BPO2.5) gel on atrophic scars in moderate or severe acne vulgaris.
In Part 1 of this two-part study, A0.3/BPO2.5 gel or vehicle was applied on each half-face for 24 weeks in a randomized, investigator-blinded, split-face design. Part 2 was a 24-week, open-label extension phase during which A0.3/BPO2.5 gel was applied on both sides of the face. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, local tolerability, and safety.
Of the 45 subjects entering Part 2, 41 completed the 48-week study. At baseline (Part 1), most subjects had moderate acne (93.3%) with mild scars (62.2%). The scar count decrease from baseline was 21.7% at week 24 and 26.9% at week 48 on the half-face treated for 48 weeks with A0.3/BPO2.5. For the half-face treated with vehicle followed by 24 weeks’ A0.3/BPO2.5, scar count increased by 16.7% at week 24 (under vehicle) and decreased by 22.7% between weeks 24 and 48. The half-face that received 48 weeks’ A0.3/BPO2.5 had a lower final atrophic scar count (mean 8.4 vs. 9.9 for the half-face with 24 weeks’ vehicle then 24 weeks’ A0.3/BPO2.5) and a higher percentage of SGA clear/almost clear. High reductions in acne lesions between baseline and week 48 were observed for both sides of the face. Long-term treatment with A0.3/BPO2.5 was safe and well-tolerated.
Reductions in atrophic acne scars and acne lesions observed after 24 weeks of treatment with A0.3/BPO2.5 gel were maintained with treatment up to 48 weeks. The additional improvement in atrophic scar count with 48 weeks’ A0.3/BPO2.5 treatment, compared to delayed application at 24 weeks, highlights the importance of early initiation of effective acne treatment to prevent and reduce the formation of acne scars.
ClinicalTrials.gov identifier NCT02735421.
The authors thank Helen Simpson, PhD, of My Word Medical Writing for providing medical writing support, which was funded by Galderma in accordance with Good Publication Practice (GPP3) guidelines. The authors are responsible for all content and editorial decisions and received no honoraria related to the development of this publication.
Compliance with Ethical Standards
This study was funded by Galderma R&D.
Conflict of interest
The investigators (BD, RB, AG-H, BB, CL, JT) received financial support for conducting the study. Dr B. Dréno has been an investigator and/or consultant for Bioderma, Galderma, Pierre Fabre, and La Roche Posay. Dr R. Bissonnette has been an investigator, consultant, advisory board member, and speaker for BioPharmX, Cipher, Dermira, Galderma, GSK-Stiefel, Valeant, and Xenon and is a shareholder of Innovaderm Research. Dr A. Gagné-Henley has been an investigator, consultant, advisory board member, and/or speaker for Abbvie, Celgene, Dignity, Galderma, Janssen, Leo Pharma, Novartis, Sanofi, Valeant, and Xenon. Dr B. Barankin has been a consultant and speaker for Galderma. Dr C. Lynde has been a consultant, advisory board member, and speaker for Bayer, Galderma, GSK, and Valeant. Dr J. Tan has been an investigator, consultant, advisory board member, and speaker, and has provided expert testimony, for Galderma. Dr R. Chavda is an employee of Galderma and Mr N. Kerrouche is a previous employee of Galderma.
This study was conducted in accordance with the principles of the Declaration of Helsinki and in compliance with the International Conference on Harmonization-Good Clinical Practice and local regulatory requirements. The study was reviewed and approved by the appropriate Independent Ethics Committees, and written informed consent was obtained from all subjects prior to study initiation. Additional informed consent was obtained from all individual participants whose photographs are included in this article.
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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