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

A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis

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.

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