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Am J Clin Dermatol. 2019 Jun 17. doi: 10.1007/s40257-019-00454-6. [Epub ahead of print]

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.

Author information

1
Department of Dermato-Cancerology, CIC 1413, CRCINA Inserm 1232, CHU Nantes, Nantes, France. brigitte.dreno@atlanmed.fr.
2
Innovaderm Research, Montréal, Québec, Canada.
3
Dre Angélique Gagné-Henley MD Inc., St-Jérôme, Québec, Canada.
4
Toronto Research Centre Inc, Toronto, Ontario, Canada.
5
Lynde Institute for Dermatology, Markham, Ontario, Canada.
6
Galderma SA, La Tour-de-Peilz, Switzerland.
7
Galderma R&D, Sophia Antipolis, France.
8
University of Western Ontario, London, Ontario, Canada.
9
Windsor Clinical Research Inc., Windsor, Ontario, Canada.

Abstract

BACKGROUND:

Scarring is a frequent consequence of acne.

OBJECTIVES:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT02735421.

PMID:
31209851
DOI:
10.1007/s40257-019-00454-6

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