Back to resultsSteroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pimecrolimus
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Pimecrolimus
Vehicle
Outcomes
Primary Outcome Measures
Corticoid-sparing effect of pimecrolimus cream 1%
Secondary Outcome Measures
atopic dermatitis control
safety of pimecrolimus cream 1%
quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00351052
Brief Title
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecroliums cream 1 % bid.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle control (placebo) bid.
Primary Outcome Measure Information:
Title
Corticoid-sparing effect of pimecrolimus cream 1%
Secondary Outcome Measure Information:
Title
atopic dermatitis control
Title
safety of pimecrolimus cream 1%
Title
quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis AG
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
City
Investigational Site
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis
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