A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face
Phase 2
Completed
- Conditions
- Seborrheic Dermatitis on the Face
- Interventions
- Drug: Azelaic Acid 15% GelDrug: Inactive 15% gel base
- Registration Number
- NCT00408330
- Lead Sponsor
- LEO Pharma
- Brief Summary
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.
- Detailed Description
To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Azelaic Acid 15% Gel azelaic acid 15% 2 Inactive 15% gel base Inactive 15% gel base
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms Measurement of parameters during the course of treatment (six weeks)