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

Phase 4

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: tacrolimus ointment; Drug: pimecrolimus cream

• Registration Number: NCT00666159
• Lead Sponsor: Astellas Pharma Inc

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

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tacrolimus ointment	-
2	pimecrolimus cream	-

Primary Outcome Measures

Name	Time	Method
Change Eczema Area and Severity Index (EASI)	6 Weeks

Secondary Outcome Measures

Name	Time	Method
Investigator's Global Atopic Dermatitis Assessment (IGADA)	6 Weeks
Patient's evaluation of itch	6 Weeks
Body surface area affected	6 Weeks