Conditions: Papulopustular Rosacea
Keywords: Rosacea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 961
Healthy volunteers: no

Brief 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.

Detailed description:
To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment.

Evaluation of all adverse events will be covered in Adverse Events section.

Arms:
arm 1: 0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks. arm 2: 0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.

Interventions: intervention 1: Azelaic acid foam, 15% (BAY39-6251) intervention 2: Vehicle foam
Intervention descriptions: intervention 1: Azelaic acid twice daily topical application intervention 2: twice daily topical application

Protocol document: