Status:
COMPLETED
A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis
Lead Sponsor:
LEO Pharma
Collaborating Sponsors:
Bayer
Conditions:
Perioral Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00403949
Start Date
November 1 2006
End Date
March 1 2007
Last Update
June 9 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Berlin, Germany, 10827
2
Dülmen, Germany, 48249
3
Essen, Germany, 45122
4
Recklinghausen, Germany, 45661