A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.

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

Details

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

Criteria

Inclusion Criteria:

• Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician

• Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)

• 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)

Exclusion Criteria:

• History of atopic dermatitis of the face

• Granulomatous perioral dermatitis

• Facial acne, rosacea, facial demodicosis

• Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus

• The use of topical or systemic medications that could affect the course of treatment and/or evaluation

• Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)

• Use of fluorinated toothpaste

• Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study

• Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study

• History of or suspected hypersensitivity to any ingredient of the study drugs

• Participation in another clinical study 4 weeks prior to and/or during the conduct of this study