Dermatitis, Atopic
Conditions
Keywords
Atopic Dermatitis, Protopic, Pediatric
Brief summary
Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis
Detailed description
This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe 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
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's 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 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