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

September 17, 2014 updated by: Astellas Pharma Inc

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
    • Florida
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33155
    • Illinois
      • Chicago, Illinois, United States, 60614
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Clinton Township, Michigan, United States, 48038
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • Nevada
      • Reno, Nevada, United States, 89511
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
      • Wilmington, North Carolina, United States, 28401
      • Winston Salem, North Carolina, United States, 27157
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: tacrolimus ointment
topical
Other Names:
  • Protopic
  • FK506 ointment
Active Comparator: 2
Drug: pimecrolimus cream
topical
Other Names:
  • Elidel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change Eczema Area and Severity Index (EASI)
Time Frame: 6 Weeks
6 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-02-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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