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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 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 452 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00446043
The ClinicalTrials.gov registry entry for NCT00446043 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 452 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 1 intervention - of which Adapalene/Benzoyl Peroxide is the first listed.
NCT00446043 reports 0 study locations.
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.
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