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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00351052
Collaborator
(none)
184
Enrollment
1
Location
2
Arms
33
Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2001
Actual Study Completion Date :
Sep 1, 2004

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Corticoid-sparing effect of pimecrolimus cream 1% []

    Secondary Outcome Measures

    1. atopic dermatitis control []

    2. safety of pimecrolimus cream 1% []

    3. quality of life []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Germany

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Chair: Novartis AG, Novartis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00351052
    Other Study ID Numbers:
    • CASM981CDE10
    First Posted:
    Jul 12, 2006
    Last Update Posted:
    Jan 17, 2008
    Last Verified:
    Jan 1, 2008
    Keywords provided by , ,
    Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema
    Pimecrolimus

    Study Results

    No Results Posted as of Jan 17, 2008