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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 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 1,668 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422240
The ClinicalTrials.gov registry entry for NCT00422240 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,668 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Gel Vehicle is the first listed.
NCT00422240 reports 0 study locations.
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.
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