Phase 3
N=1,668
Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00422240 ↗Enrolled (actual)
1,668
Serious AEs
0.4%
Results posted
Apr 2024
Primary outcome: Primary: Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) — 30.1; 19.8; 22.2; 11.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adapalene/Benzoyl Peroxide (Drug); Adapalene Gel, 0.1% (Drug); Benzoyl Peroxide Gel 2.5% (Drug); Gel Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) |
30.1; 19.8; 22.2; 11.3 | — |
| PRIMARY Change in Inflammatory Lesion Count From Baseline to Week 12 |
27.0; 27.0; 27.0; 27.0; -16.0; -14.0 | — |
| PRIMARY Change in Noninflammatory Lesion Count From Baseline to Week 12 |
44.0; 47.0; 46.0; 46.0; -24.0; -22.0 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 |
-55.33; -41.68; -47.61; -30.23 | — |
| SECONDARY Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 |
-48.15; -40.75; -37.23; -23.22 | — |
| SECONDARY Percent Change From Baseline in Total Lesion Counts at Week 12 |
-49.97; -41.29; -41.23; -26.06 | — |
Summary
This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.
The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of acne vulgaris with facial involvement.
- A minimum of 20 but not more than 50 inflammatory lesions
- A minimum of 30 but not more than 100 noninflammatory lesions
- A score of 3 (Moderate) on the Investigator's Global Assessment Scale
Data sourced from ClinicalTrials.gov (NCT00422240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.