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NCT00031096 · ClinicalTrials.gov registry record · Phase 3
Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
A Phase 3 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 879
- Enrollment target
NCT00031096: Completed Phase 3 study, sponsored by LEO Pharma.
NCT00031096 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 879 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00031096, a Phase 3 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 879 participants
- Enrollment target
Study Summary
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
Interventions
- DRUG Azelaic Acid Gel 15% (Finacea, BAY39-6251)
- DRUG Vehicle gel (SH H 655 PBA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 879 participants |
| Start Date | 2002-01 |
| Est. Completion | 2002-07 |
| Phase | Phase 3 |
What the finished NCT00031096 record still lists
NCT00031096 is an interventional study that assigns participants to a tested intervention. The registered 879 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 2 interventions - of which Azelaic Acid Gel 15% (Finacea, BAY39-6251) is the first listed.
NCT00031096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00031096 about?
NCT00031096 is a clinical study titled "Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne". Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
What is the current status of trial NCT00031096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 879 participants. The study started on 2002-01. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00031096?
The interventions under investigation include: Azelaic Acid Gel 15% (Finacea, BAY39-6251) (DRUG), Vehicle gel (SH H 655 PBA) (DRUG).
Who is sponsoring clinical trial NCT00031096?
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 NCT00031096's enrollment target sits among peer trials
879 370th of 2000 higher than 1,631 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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