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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Perioral Dermatitis

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

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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.


Inclusion Criteria:

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


- 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

Locations and Contacts

Berlin 10827, Germany

Dülmen 48249, Germany

Essen 45122, Germany

Recklinghausen 45661, Germany

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: November 2006
Last updated: February 15, 2015

Page last updated: August 20, 2015

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