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

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

Phase

4

Condition

Allergy

Atopic Dermatitis

Rash

Treatment

N/A

Clinical Study ID

NCT00666302
20-02-004
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's GlobalAtopic Dermatitis Assessment involving a minimum of 5% of the body surface area

  • Negative pregnancy test and agrees to practice effective birth control during thestudy

Exclusion

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 wouldinterfere with rating of efficacy parameters

  • Clinically infected Atopic Dermatitis at baseline

  • Likely to require systemic corticosteroids; or likely to require intranasal or inhaledcorticosteroids for an off-label indication or at higher doses than the maximumlabeled 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

Study Design

Total Participants: 413
Study Start date:
October 01, 2002
Estimated Completion Date:
November 30, 2003

Connect with a study center

  • Halifax, Nova Scotia B3H 1Z4
    Canada

    Site Not Available

  • Birmingham, Alabama 35205
    United States

    Site Not Available

  • San Francisco, California 94118
    United States

    Site Not Available

  • Kansas City, Kansas 66160
    United States

    Site Not Available

  • Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • St Louis, Missouri 63110
    United States

    Site Not Available

  • New York, New York 10029
    United States

    Site Not Available

  • Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Dallas, Texas 75230
    United States

    Site Not Available

  • San Antonio, Texas 78229
    United States

    Site Not Available

  • Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Norfolk, Virginia 23507
    United States

    Site Not Available

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