A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
Phase 4
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT00666302
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 413
Inclusion Criteria
- Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
- Negative pregnancy test and agrees to practice effective birth control during the study
Exclusion Criteria
- Skin disorder other than Atopic Dermatitis in the areas to be treated
- Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
- Clinically infected Atopic Dermatitis at baseline
- Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
- Known hypersensitivity to macrolides or any excipient of either study medication
- Chronic condition which is either not stable or not well controlled
- Pregnant or breast feeding an infant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tacrolimus ointment - 2 pimecrolimus cream -
- Primary Outcome Measures
Name Time Method Change in Eczema Area and Severity Index (EASI) 6 Weeks
- Secondary Outcome Measures
Name Time Method Investigator's Global Atopic Dermatitis Assessment (IGADA) 6 Weeks Patient's evaluation of itch 6 Weeks Body surface area affected 6 Weeks