Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis

Detailed Description
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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

Official Title
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A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Moderate to Severe Atopic Dermatitis

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: tacrolimus ointment
* Drug: pimecrolimus cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tacrolimus ointment<br>* topical<br>* Other names: FK506 ointment;|
| Active Comparator: 2<br> | Drug: pimecrolimus cream<br>* topical<br>* Other names: Elidel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Eczema Area and Severity Index (EASI) |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Atopic Dermatitis Assessment (IGADA) |  | 6 Weeks | 
| Patient's evaluation of itch |  | 6 Weeks | 
| Body surface area affected |  | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Protopic, Pediatric