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

Last updated: September 17, 2014
Sponsor: Astellas Pharma Inc
Overall Status: Completed

Phase

4

Condition

Rash

Dermatitis, Atopic

Allergy

Treatment

N/A

Clinical Study ID

NCT00667160
20-02-006
  • Ages 2-16
  • All Genders

Study Summary

A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator'sGlobal Atopic Dermatitis Assessment involving a minimum of 5% of the body surfacearea, and the maximum of 20% of the body surface area

  • If female, and of childbearing potential, patient has a negative pregnancy test andagrees to practice effective birth control during the study

Exclusion

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 thatwould 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 torequire intranasal or inhaled corticosteroids for an off-label indication or at higherdoses than the maximum labeled dosing for the drug

  • Patient has a known hypersensitivity to macrolides or any excipient of either studymedication

  • Patient has a chronic condition which is either not stable or not well controlled

  • Patient is pregnant or breast feeding an infant

Study Design

Total Participants: 426
Study Start date:
December 01, 2002
Estimated Completion Date:
November 30, 2003

Connect with a study center

  • San Diego, California 92123
    United States

    Site Not Available

  • New Haven, Connecticut 06519
    United States

    Site Not Available

  • Miami, Florida 33155
    United States

    Site Not Available

  • Chicago, Illinois 60614
    United States

    Site Not Available

  • Boston, Massachusetts 02115
    United States

    Site Not Available

  • Clinton township, Michigan 48308
    United States

    Site Not Available

  • Fridley, Minnesota 55432
    United States

    Site Not Available

  • Omaha, Nebraska 68144
    United States

    Site Not Available

  • Reno, Nevada 89511
    United States

    Site Not Available

  • Durham, North Carolina 27705
    United States

    Site Not Available

  • Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Cleveland, Ohio 44106
    United States

    Site Not Available

  • Portland, Oregon 97201
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania 15218
    United States

    Site Not Available

  • Dallas, Texas 75390
    United States

    Site Not Available

  • Galveston, Texas 77555
    United States

    Site Not Available

  • Houston, Texas 62016
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.