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

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

Study Type: Interventional

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

Study Primary Completion Date: November 2003

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 in 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 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

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/NCT00666302

Study ID Number: 20-02-004

ClinicalTrials.gov Identifier: NCT00666302

Health Authority: United States: Institutional Review Board

Link to results on ClinicalStudyResults.org