Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Inclusion Criteria:

• male and female patient at least 18 years of age
• signed informed consent
• Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
• Ability and willingness to accept and comply with treatment and required medical examinations

Exclusion Criteria:

• Known non-responders to azelaic acid
• Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
• Presence of dermatoses that could interfere with the rosacea diagnosis
• Treatment with isotretinoin in the six months prior to randomization
• Treatment of the face with topical retinoids during the two weeks prior to randomization
• Treatment with oral antibiotics during the four weeks prior to randomization
• Treatment with topical antibiotics
• Treatment with systemic corticosteroids during 4 weeks prior to randomization
• Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
• Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
• Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
• Use of a sauna during 2 weeks prior to randomization and during the study
• Facial laser surgery for telangiectasia during 6 weeks prior to randomization
• Planned concurrent use of any treatment other than study medication that affects rosacea
• History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
• Participation in another clinical trial during the last 4 weeks