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Clinical Trials/NCT00666302
NCT00666302
Completed
Phase 4

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

Astellas Pharma Inc0 sites413 target enrollmentOctober 2002
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ConditionsDermatitis, Atopic
Interventionstacrolimus ointmentpimecrolimus cream
Drugstacrolimus ointmentpimecrolimus cream

Overview

Phase
Phase 4
Intervention
tacrolimus ointment
Conditions
Dermatitis, Atopic
Sponsor
Astellas Pharma Inc
Enrollment
413
Primary Endpoint
Change in Eczema Area and Severity Index (EASI)
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
November 2003
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

1

Intervention: tacrolimus ointment

2

Intervention: pimecrolimus cream

Outcomes

Primary Outcomes

Change in Eczema Area and Severity Index (EASI)

Time Frame: 6 Weeks

Secondary Outcomes

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

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