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

Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris / complications
  • Acne Vulgaris / diagnosis
  • Acne Vulgaris / drug therapy*
  • Adapalene, Benzoyl Peroxide Drug Combination / administration & dosage*
  • Adapalene, Benzoyl Peroxide Drug Combination / adverse effects
  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Atrophy / etiology
  • Atrophy / prevention & control
  • Cicatrix / etiology
  • Cicatrix / prevention & control*
  • Female
  • Gels
  • Humans
  • Male
  • Severity of Illness Index
  • Skin / drug effects
  • Skin / pathology*
  • Time Factors
  • Time-to-Treatment
  • Treatment Outcome
  • Young Adult


  • Adapalene, Benzoyl Peroxide Drug Combination
  • Anti-Inflammatory Agents, Non-Steroidal
  • Gels

Associated data

  • ClinicalTrials.gov/NCT02735421