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A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With 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.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 961 |
| Start date | 2012-09 |
| Completion | 2014-01 |
Conditions
- Papulopustular Rosacea
Interventions
- Azelaic acid foam, 15% (BAY39-6251)
- Vehicle foam
Primary outcomes
- Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) — At end of treatment (LOCF), up to 12 weeks
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; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal. - Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF) — Baseline and end of treatment (LOCF), up to 12 weeks
The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.
Countries
United States