NCT02735421

Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars

Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face). Participants with each half-face randomized to one of the two following treatments: * Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte). * Vehicle gel The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.

Conditions

• Acne Vulgaris
• Atrophic Acne Scars

Interventions

Type	Name	Description
DRUG	ABPO Forte Gel	Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.
DRUG	Vehicle gel	Participants applied placebo matched to ABPO Forte gel topically to the affected areas once daily for 24 weeks in Part 1 and 48 weeks in Part 2.

Timeline

• Start date: 2016-05-13
• Primary completion: 2017-06-05
• Completion: 2017-11-23
• First posted: 2016-04-12
• Last updated: 2022-09-14
• Results posted: 2019-11-15

Locations

7 sites across 2 countries: Canada, France