Seborrheic Dermatitis on the Face Clinical Trial
Official title:
A Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face
| Verified date | March 2015 |
| Source | LEO Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | March 2007 |
| Est. primary completion date | March 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Stable or exacerbating seborrheic dermatitis in the facial area Exclusion Criteria: - Psoriasis - Atopic dermatitis - Facial acne and rosacea - Dermatophytic skin infections - Parkinson's disease - Known immunosuppression; HIV infection - Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy - Continuous asthma inhalation treatment requiring > 800 mg corticosteroids - Any severe disease likely to interfere with the conduct or the planned termination of the study |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| LEO Pharma | Bayer |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment. | Measurement of parameters during the course of treatment (six weeks) | ||
| Secondary | Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms | Measurement of parameters during the course of treatment (six weeks) |