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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2003

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

Intervention(s) in this Clinical Trial

• Drug: tacrolimus ointment
  • topical
• Drug: pimecrolimus cream
  • topical

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Change Eczema Area and Severity Index (EASI)
  • Time Frame: 6 Weeks
    Safety Issue?: No

Secondary Measures

• Investigator's Global Atopic Dermatitis Assessment (IGADA)
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Patient's evaluation of itch
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Body surface area affected
  • Time Frame: 6 Weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use central contact Study Director Astellas Pharma US, Inc.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666159

Study ID Number: 20-02-005

ClinicalTrials.gov Identifier: NCT00666159

Health Authority: United States: Institutional Review Board

Link to results on ClinicalStudyResults.org