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Topical Retinoid and Benzoyl Peroxide Combination

Adapalene / BPO gel for Acne Vulgaris (EDeN Trial)

Phase 3
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 12
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

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).

Eligible Conditions
  • Acne Vulgaris
  • Acne

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire

Side effects data

From 2018 Phase 3 trial • 50 Patients • NCT02932267
6%
Headache
4%
Pyrexia
4%
Post inflammatory pigmentation change
4%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adapalene / BPO Gel

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adapalene / BPO gelExperimental Treatment1 Intervention
Adapalene 0.3% / BPO 2.5% gel, once daily in the evening
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adapalene
FDA approved

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,637 Total Patients Enrolled
47 Trials studying Acne Vulgaris
15,473 Patients Enrolled for Acne Vulgaris
~6 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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