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

Condition(s) targeted: Perioral Dermatitis

Intervention: Azelaic Acid 15% Gel (Drug); Azelaic acid 15% gel (Drug); Non-active base from azelaic acid 15% gel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Intendis GmbH

Official(s) and/or principal investigator(s):
Intendis GmbH, Study Director, Affiliation: +49 30 5200 75 802

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The sum score derived from the most important signs and symptoms of perioral dermatitis

Secondary outcome:

Intensity of single signs and symptoms

Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Intendis GmbH, Berlin, Germany

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Starting date: November 2006
Ending date: March 2007
Last updated: December 3, 2007