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NCT00421993 · ClinicalTrials.gov registry record · Phase 3
A 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
- 1,670
- Enrollment target
NCT00421993: Completed Phase 3 study, sponsored by Galderma R&D.
NCT00421993 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 1,670 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
NCT00421993, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,670 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be 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 subject should remain the same during the study. The primary objective is 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
Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe)
Interventions
- DRUG Benzoyl Peroxide
- DRUG Adapalene
- DRUG Adapalene/Benzoyl Peroxide
- DRUG Topical Gel Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,670 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00421993 record still lists
NCT00421993 is an interventional study that assigns participants to a tested intervention. Its 1,670 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 Benzoyl Peroxide is the first listed.
NCT00421993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00421993 about?
NCT00421993 is a clinical study titled "A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris". This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters ...
What is the current status of trial NCT00421993?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,670 participants. The study started on 2006-10. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00421993?
The interventions under investigation include: Benzoyl Peroxide (DRUG), Adapalene (DRUG), Adapalene/Benzoyl Peroxide (DRUG), Topical Gel Vehicle (DRUG).
Who is sponsoring clinical trial NCT00421993?
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 NCT00421993's enrollment target sits among peer trials
1,670 136th 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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