NCT02932267

Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne

Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide 2.5% in Moderate to Severe Acne in Dark Skin Phototype Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face. All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face. The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene 0.3% / BPO 2.5% gel	Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Timeline

• Start date: 2017-02-02
• Primary completion: 2018-01-10
• Completion: 2018-01-10
• First posted: 2016-10-13
• Last updated: 2021-02-18
• Results posted: 2019-11-15

Locations

3 sites across 3 countries: United States, Mauritius, Singapore

Regulatory

• FDA-regulated drug study