NCT01555463

Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 961 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Papulopustular Rosacea

Interventions

Type	Name	Description
DRUG	Azelaic acid foam, 15% (BAY39-6251)	Azelaic acid twice daily topical application
DRUG	Vehicle foam	twice daily topical application

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-03-15
• Last updated: 2023-06-09
• Results posted: 2015-01-27

Locations

49 sites across 1 country: United States