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NCT00446043 · ClinicalTrials.gov registry record · Phase 3
Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
A Phase 3 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 452
- Enrollment target
NCT00446043: Completed Phase 3 study, sponsored by Galderma R&D.
NCT00446043 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 452 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00446043, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 452 participants
- Enrollment target
Study Summary
This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.
Primary Outcome
Percent change in inflammatory, noninflammatory and total lesions at Month 12 was measured from baseline lesions. The noninflammatory lesion count was the sum of open comedones (a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead) and closed comedones (a mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). The inflammatory lesion count was the sum of papules (a small, solid elevation less than 1.0 cm in diameter) and p
Interventions
- DRUG Adapalene/Benzoyl Peroxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2004-02-17 |
| Est. Completion | 2005-05-23 |
| Phase | Phase 3 |
What the finished NCT00446043 record still lists
NCT00446043 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 1 intervention - of which Adapalene/Benzoyl Peroxide is the first listed.
NCT00446043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00446043 about?
NCT00446043 is a clinical study titled "Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects". This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel. Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12. Safety was evaluated by spontaneous reports of Adverse Ev...
What is the current status of trial NCT00446043?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2004-02-17. Estimated completion is 2005-05-23.
What interventions are being tested in trial NCT00446043?
The interventions under investigation include: Adapalene/Benzoyl Peroxide (DRUG).
Who is sponsoring clinical trial NCT00446043?
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 NCT00446043's enrollment target sits among peer trials
452 835th of 2000 higher than 1,165 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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