Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

January 10, 2008 updated by: Novartis
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

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
    • California
      • Huntington Beach, California, United States, 92647
        • Pediatric Care Medical Group, Inc.
      • San Diego, California, United States, 92123
        • Children's Hospital -San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Dermatology Associates and Research
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia - Clinical Investigative Services
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center Section of Dermatology
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine Dept. of Dermatology
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Calcagno Research and Development
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • 520 Trinity Creek Cove
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98105
        • A.S.T.H.M.A., Inc

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

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe atopic dermatitis
  • 5% of total body surface area (TBSA) affected

Exclusion Criteria:

  • Concurrent skin diseases (infections)
  • Immunocompromised
  • Recently received phototherapy or systemic therapy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pimecrolimus 1 % cream plus topical corticosteroid (TCS)
Drug: Pimecrolimus plus topical corticosteroid (TCS)
Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily
Other Names:
  • Elidel
Placebo Comparator: 2
Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
twice daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation)

Secondary Outcome Measures

Outcome Measure
Incidence of all other adverse events
Time to relapse of atopic dermatitis
Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity)
Efficacy measured by IGA (treatment success and improvement)
Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent

Collaborators and Investigators

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

Sponsor

Novartis

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

May 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 14, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981C2439

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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