Advertisement

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

  • Brigitte DrénoEmail author
  • Robert Bissonnette
  • Angélique Gagné-Henley
  • Benjamin Barankin
  • Charles Lynde
  • Rajeev Chavda
  • Nabil Kerrouche
  • Jerry Tan
Short Communication

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.

Notes

Acknowledgements

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

Funding

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.

Ethical approval

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.

Data-sharing statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. 1.
    Koo JY, Smith LL. Psychologic aspects of acne. Pediatr Dermatol. 1991;8(3):185–8 (Review).CrossRefGoogle Scholar
  2. 2.
    Thiboutot DM, Dréno B, Abanmi A, Alexis AF, Araviiskaia E, Barona Cabal MI, et al. Practical management of acne for clinicians: an international consensus from the Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2018;78(2 Suppl 1):S1–23.CrossRefGoogle Scholar
  3. 3.
    Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and severe inflammatory acne vulgaris effectively treated with single-agent therapy by a new fixed-dose combination adapalene 0.3%/benzoyl peroxide 2.5 % gel: a randomized, double-blind, parallel-group, controlled study. Am J Clin Dermatol. 2016;17(3):293–303.CrossRefGoogle Scholar
  4. 4.
    Dréno B, Tan J, Rivier M, Martel P, Bissonnette R. Adapalene 0.1%/benzoyl peroxide 2.5% gel reduces the risk of atrophic scar formation in moderate inflammatory acne: a split-face randomized controlled trial. J Eur Acad Dermatol Venereol. 2017;31(4):737–42.CrossRefGoogle Scholar
  5. 5.
    Dréno B, Bissonnette R, Gagné-Henley A, Barankin B, Lynde C, Kerrouche N, et al. 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. Am J Clin Dermatol. 2018;19(2):275–86.CrossRefGoogle Scholar
  6. 6.
    Galderma. Adapalene 0.3% - benzoyl peroxide 2.5% gel and risk of formation of atrophic acne scars (OSCAR) [ClinicalTrials.gov identifier NCT02735421]. US National Institutes of Health, ClinicalTrials.gov. https://www.clinicaltrials.gov. Accessed 21 May 2019.
  7. 7.
    Loss MJ, Leung S, Chien A, Kerrouche N, Fischer AH, Kang S. Adapalene 0.3% gel shows efficacy for the treatment of atrophic acne scars. Dermatol Ther (Heidelb). 2018;8(2):245–57.CrossRefGoogle Scholar
  8. 8.
    Tan J, Bourdès V, Bissonnette R, Petit B, Eng L, Reynier P, et al. Prospective study of pathogenesis of atrophic acne scars and role of macular erythema. J Drugs Dermatol. 2017;16(6):566–72.Google Scholar
  9. 9.
    Weiss J, Stein Gold L, Leoni M, Rueda MJ, Liu H, Tanghetti E. Customized single-agent therapy management of severe inflammatory acne: a randomized, double-blind, parallel-group, controlled study of a new treatment—adapalene 0.3%-benzoyl peroxide 2.5% gel. J Drugs Dermatol. 2015;14(12):1427–35.Google Scholar
  10. 10.
    Poulin Y, Sanchez NP, Bucko A, Fowler J, Jarratt M, Kempers S, et al. A 6-month maintenance therapy with adapalene-benzoyl peroxide gel prevents relapse and continuously improves efficacy among patients with severe acne vulgaris: results of a randomized controlled trial. Br J Dermatol. 2011;164(6):1376–82.CrossRefGoogle Scholar
  11. 11.
    Tan J, Stein Gold L, Schlessinger J, Brodell R, Jones T, Cruz A, et al. Short-term combination therapy and long-term relapse prevention in the treatment of severe acne vulgaris. J Drugs Dermatol. 2012;11(2):174–80.Google Scholar
  12. 12.
    Bouloc A, Roo E, Imko-Walczuk B, Moga A, Chadoutaud B, Dréno B. A skincare combined with combination of adapalene and benzoyl peroxide provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne. J Eur Acad Dermatol Venereol. 2017;31(10):1727–31.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Brigitte Dréno
    • 1
    Email author
  • Robert Bissonnette
    • 2
  • Angélique Gagné-Henley
    • 3
  • Benjamin Barankin
    • 4
  • Charles Lynde
    • 5
  • Rajeev Chavda
    • 6
  • Nabil Kerrouche
    • 7
  • Jerry Tan
    • 8
    • 9
  1. 1.Department of Dermato-CancerologyCIC 1413, CRCINA Inserm 1232, CHU NantesNantesFrance
  2. 2.Innovaderm ResearchMontréalCanada
  3. 3.Dre Angélique Gagné-Henley MD Inc.St-JérômeCanada
  4. 4.Toronto Research Centre IncTorontoCanada
  5. 5.Lynde Institute for DermatologyMarkhamCanada
  6. 6.Galderma SALa Tour-de-PeilzSwitzerland
  7. 7.Galderma R&DSophia AntipolisFrance
  8. 8.University of Western OntarioLondonCanada
  9. 9.Windsor Clinical Research Inc.WindsorCanada

Personalised recommendations