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NCT01025635 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
A Phase 2 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 401
- Enrollment target
NCT01025635: Completed Phase 2 study, sponsored by LEO Pharma.
NCT01025635 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 401 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01025635, a Phase 2 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 401 participants
- Enrollment target
Study Summary
This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
Primary Outcome
The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate er
Interventions
- DRUG Vehicle foam
- DRUG Azelaic acid foam 15%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 401 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT01025635 record still lists
NCT01025635 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher).
The record links to 0 conditions, and to 2 interventions - of which Vehicle foam is the first listed.
NCT01025635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01025635 about?
NCT01025635 is a clinical study titled "Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea". This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
What is the current status of trial NCT01025635?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 401 participants. The study started on 2009-12. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01025635?
The interventions under investigation include: Vehicle foam (DRUG), Azelaic acid foam 15% (DRUG).
Who is sponsoring clinical trial NCT01025635?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01025635's enrollment target sits among peer trials
401 96th of 2000 higher than 1,905 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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