Perioral Dermatitis
Conditions
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.
Interventions
gel, applied once daily, for 6 weeks
DRUGNon-active base from azelaic acid 15% gel
gel, apply once daily for six weeks
Sponsors
Bayer
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sum score derived from the most important signs and symptoms of perioral dermatitis | Measurements and observations during the course of the study |
Secondary
| Measure | Time frame |
|---|---|
| Intensity of single signs and symptoms | 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 investigator | Safety parameters recorded at scheduled visits during the course of the study |
Countries
Germany
Outcome results
None listed