Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
- Registration Number
- NCT00130364
- Lead Sponsor
- Novartis
- Brief Summary
This study is not being conducted in the United States of America (USA).
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Mild to moderate facial atopic dermatitis
- Patients intolerant of, or dependent on, topical corticosteroids
Exclusion Criteria
- Concurrent skin diseases (infections)
- Immunocompromised
- Recently received phototherapy or systemic therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Pimecrolimus vehicle cream 1 Pimecrolimus Pimecrolimus
- Primary Outcome Measures
Name Time Method The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
- Secondary Outcome Measures
Name Time Method Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild) Time to clearance of facial IGA (score of 0 or 1)
Trial Locations
- Locations (1)
This study is not being conducted in the United States
🇺🇸Novartis Pharmaceuticals, New Jersey, United States