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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00351052

First received: July 10, 2006

Last updated: January 15, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

July 10, 2006

Last Updated Date

January 15, 2008

Start Date ^ICMJE

December 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Corticoid-sparing effect of pimecrolimus cream 1%

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00351052 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: Pimecrolimus
Pimecroliums cream 1 % bid.

Other Name: Elidel
Drug: Placebo
Vehicle control (placebo) bid.

Study Arm (s)

Experimental: 1
Pimecrolimus

Intervention: Drug: Pimecrolimus
Placebo Comparator: 2
Vehicle

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

184

Completion Date

September 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 18 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00351052

Other Study ID Numbers ^ICMJE

CASM981CDE10

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis AG

Novartis

Information Provided By

Novartis

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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