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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 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 1,670 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00421993
The ClinicalTrials.gov registry entry for NCT00421993 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,670 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 Benzoyl Peroxide is the first listed.
NCT00421993 reports 0 study locations.
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.
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