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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxisklinik and Gemeinschaftspraxis Dülmen, Germany, 48249 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Haut- and Geschlechtskrankheiten, Phlebologie- Berufsdermatologie Recklinghausen, Germany, 45661 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hautarztpraxis Berlin, Germany, 10827 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- The sum score derived from the most important signs and symptoms of perioral dermatitisTimeframe: Measurements and observations during the course of the study
Secondary Outcome
- Intensity of single signs and symptomsTimeframe: Measured at scheduled visits during the course of the study
- Safety outcomes measures will be all adverse events reported by the patients or observed by the investigatorTimeframe: Safety parameters recorded at scheduled visits during the course of the study
Additional Information
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