Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01555463 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
A Phase 3 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 961
- Enrollment target
NCT01555463: Completed Phase 3 study, sponsored by LEO Pharma.
NCT01555463 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 961 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555463, a Phase 3 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 961 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.
Primary Outcome
Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; m
Interventions
- DRUG Vehicle foam
- DRUG Azelaic acid foam, 15% (BAY39-6251)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 961 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01555463 record still lists
NCT01555463 is an interventional study that assigns participants to a tested intervention. The registered 961 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 (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Vehicle foam is the first listed.
NCT01555463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01555463 about?
NCT01555463 is a clinical study titled "Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea". The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.
What is the current status of trial NCT01555463?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 961 participants. The study started on 2012-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01555463?
The interventions under investigation include: Vehicle foam (DRUG), Azelaic acid foam, 15% (BAY39-6251) (DRUG).
Who is sponsoring clinical trial NCT01555463?
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 NCT01555463's enrollment target sits among peer trials
961 330th of 2000 higher than 1,671 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04726241 · 960 participants · Phase 1
The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study
- NCT05142384 · 960 participants · NA
ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start
- NCT05178498 · 960 participants
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
- NCT05946629 · 960 participants · NA
SELUTION 4 De Novo Small Vessel IDE Trial
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia