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NCT00249782 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
NCT00249782 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 400 participants.
The verdict
NCT00249782, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea. ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA. Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.
Interventions
- DRUG Vehicle control, 2x/day
- DRUG ACZONE (dapsone) Gel, 5%, 2x/day
- DRUG ACZONE (dapsone) Gel, 5%, 1x/day
- DRUG MetroGel® (metronidazole gel), 1.0% 1x/day
- DRUG ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00249782
The ClinicalTrials.gov registry entry for NCT00249782 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Vehicle control, 2x/day is the first listed.
NCT00249782 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00249782 about?
NCT00249782 is a clinical study titled "A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.". The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea. ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the...
What is the current status of trial NCT00249782?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2005-11. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00249782?
The interventions under investigation include: Vehicle control, 2x/day (DRUG), ACZONE (dapsone) Gel, 5%, 2x/day (DRUG), ACZONE (dapsone) Gel, 5%, 1x/day (DRUG), MetroGel® (metronidazole gel), 1.0% 1x/day (DRUG), ACZONE (dapsone) Gel, 5%, 1x/day (AM) + MetroGel (metronidazole gel), 1.0%, 1x/day (PM) (DRUG).
Who is sponsoring clinical trial NCT00249782?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
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