Trial Condition(s):

Perioral Dermatitis

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

Bayer Identifier:

1400418

ClinicalTrials.gov Identifier:

NCT00403949

EudraCT Number:

2006-002471-40

Study Completed

Trial Purpose

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

Trial Summary

Enrollment Goal
48
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Praxisklinik and Gemeinschaftspraxis

Dülmen, Germany, 48249

Status
Completed
 
Locations

Haut- and Geschlechtskrankheiten, Phlebologie- Berufsdermatologie

Recklinghausen, Germany, 45661

Status
Completed
 
Locations

Hautarztpraxis

Berlin, Germany, 10827

Status
Completed
 

Trial Design