Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

January 15, 2008 updated by: Novartis

A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis

This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

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

  • Germany
      • Investigational Site, Germany

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 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
  • responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase

Exclusion Criteria:

  • Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study

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
Drug: Pimecrolimus
Pimecroliums cream 1 % bid.
Other Names:
  • Elidel
Placebo Comparator: 2
Vehicle
Drug: Placebo
Vehicle control (placebo) bid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Corticoid-sparing effect of pimecrolimus cream 1%

Secondary Outcome Measures

Outcome Measure
quality of life
atopic dermatitis control
safety of pimecrolimus cream 1%

Collaborators and Investigators

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

Sponsor

Novartis

Investigators

  • Study Chair: Novartis AG, 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

December 1, 2001

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

July 10, 2006

First Submitted That Met QC Criteria

July 10, 2006

First Posted (Estimate)

July 12, 2006

Study Record Updates

Last Update Posted (Estimate)

January 17, 2008

Last Update Submitted That Met QC Criteria

January 15, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981CDE10

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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