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Topical Acne Medication

Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars (OSCAR Trial)

Phase 4
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: weeks 1, 4, 8, 12, 16, 20 and 24; part 2: weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

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.

Eligible Conditions
  • Cystic Acne
  • Acne
  • Atrophic Acne Scars

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: weeks 1, 4, 8, 12, 16, 20 and 24; part 2: weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: weeks 1, 4, 8, 12, 16, 20 and 24; part 2: weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Total Atrophic Acne Scar Count Per Half-face
Secondary study objectives
Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit
Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score
Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: ABPO Forte GelExperimental Treatment1 Intervention
Group II: Part 1: ABPO Forte GelExperimental Treatment1 Intervention
Group III: Part 1: ABPO Forte Vehicle GelPlacebo Group1 Intervention
Group IV: Part 2: ABPO Forte Vehicle GelPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABPO Forte Gel
2016
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,593 Total Patients Enrolled
~7 spots leftby Jan 2026
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