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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer; LEO Pharma
• Collaborator: Bayer
• Treatments: Azelaic acid

Criteria

Inclusion Criteria:

• Diagnosis of papulopustular rosacea

• Free of any clinically significant disease, which could interfere with the study

• Male or female subject aged ≥ 18 years

• Willingness of subject to follow all study procedures

• Signed written informed consent before any study-related activities are carried out

Exclusion Criteria:

• Subjects who are known to be non-responders to azelaic acid

• Presence of dermatoses that might interfere with rosacea diagnosis

• Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment

• Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study

• Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study

• Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization

• Known hypersensitivity to any ingredients of the investigational product formulation

• Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study

• Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study