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NCT00422240 · ClinicalTrials.gov registry record · Phase 3
Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
A Phase 3 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,668
- Enrollment target
NCT00422240: Completed Phase 3 study, sponsored by Galderma R&D.
NCT00422240 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 1,668 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422240, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,668 participants
- Enrollment target
Study 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.
Primary Outcome
Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with
Interventions
- DRUG Gel Vehicle
- DRUG Adapalene Gel, 0.1%
- DRUG Adapalene/Benzoyl Peroxide
- DRUG Benzoyl Peroxide Gel 2.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,668 participants |
| Start Date | 2006-06-27 |
| Est. Completion | 2007-07-12 |
| Phase | Phase 3 |
What the finished NCT00422240 record still lists
NCT00422240 is an interventional study that assigns participants to a tested intervention. Its 1,668 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (116% higher).
The record links to 0 conditions, and to 4 interventions - of which Gel Vehicle is the first listed.
NCT00422240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00422240 about?
NCT00422240 is a clinical study titled "Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris". 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 mu...
What is the current status of trial NCT00422240?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,668 participants. The study started on 2006-06-27. Estimated completion is 2007-07-12.
What interventions are being tested in trial NCT00422240?
The interventions under investigation include: Gel Vehicle (DRUG), Adapalene Gel, 0.1% (DRUG), Adapalene/Benzoyl Peroxide (DRUG), Benzoyl Peroxide Gel 2.5% (DRUG).
Who is sponsoring clinical trial NCT00422240?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00422240's enrollment target sits among peer trials
1,668 137th of 2000 higher than 1,864 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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