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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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