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NCT00835198 · ClinicalTrials.gov registry record · Phase 4
Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
A Phase 4 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 163
- Enrollment target
NCT00835198: Completed Phase 4 study, sponsored by Allergan.
NCT00835198 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 163 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835198, a Phase 4 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 163 participants
- Enrollment target
Study Summary
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
Primary Outcome
Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Interventions
- DRUG Tretinoin
- DRUG Dapsone; Tretinoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-08 |
| Phase | Phase 4 |
What the finished NCT00835198 record still lists
NCT00835198 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Tretinoin is the first listed.
NCT00835198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835198 about?
NCT00835198 is a clinical study titled "Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris". A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
What is the current status of trial NCT00835198?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 163 participants. The study started on 2008-12. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00835198?
The interventions under investigation include: Tretinoin (DRUG), Dapsone; Tretinoin (DRUG).
Who is sponsoring clinical trial NCT00835198?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835198's enrollment target sits among peer trials
163 501st of 2000 higher than 1,498 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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