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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Signed written informed consent

• Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia

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

• Willingness to follow all study procedures

• Male or female patient at least 18 years of age

Exclusion Criteria:

• Subjects known to be non-responders to azelaic acid

• Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results

• Ocular rosacea, phymatous rosacea

• Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study

• Facial laser surgery in the 6 weeks prior to the study

• Topical or systemic use of prescription or non-prescription medications to treat rosacea

• Use of any agent other than the investigational drugs to treat rosacea during the study

• Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions

• Known hypersensitivity to any ingredients of the investigational product formulation

• Alcohol or drug abuse

• Incapability of giving fully informed consent

• Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff

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