Dermatitis, Atopic
Conditions
Keywords
Mild Atopic Dermatitis, Protopic, Pediatric
Brief summary
A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients
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
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area * If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study
Exclusion criteria
* Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated * Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters * Patient has clinically infected Atopic Dermatitis at baseline * Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug * Patient has a known hypersensitivity to macrolides or any excipient of either study medication * Patient has a chronic condition which is either not stable or not well controlled * Patient is 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
United States
Outcome results
None listed