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

LEO Pharma

Status and phase

Completed

Phase 2

Conditions

Perioral Dermatitis

Treatments

Drug: Azelaic acid 15% gel

Drug: Non-active base from azelaic acid 15% gel

Study type

Interventional

Funder types

Industry

Identifiers

1400418

2006-002471-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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