Dermatitis, Atopic
Conditions
Keywords
Atopic Dermatitis, Protopic, Elidel
Brief summary
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis
Interventions
DRUGtacrolimus ointment
topical
topical
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Eczema Area and Severity Index (EASI) | 6 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's Global Atopic Dermatitis Assessment (IGADA) | 6 Weeks |
| Patient's evaluation of itch | 6 Weeks |
| Body surface area affected | 6 Weeks |
Countries
Canada, United States
Outcome results
None listed