NCT00351052
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Pimecrolimus
- Conditions
- Atopic Dermatitis
- Sponsor
- Novartis
- Enrollment
- 184
- Primary Endpoint
- Corticoid-sparing effect of pimecrolimus cream 1%
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis
Investigators
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
Arms & Interventions
1
Pimecrolimus
Intervention: Pimecrolimus
2
Vehicle
Intervention: Placebo
Outcomes
Primary Outcomes
Corticoid-sparing effect of pimecrolimus cream 1%
Secondary Outcomes
- safety of pimecrolimus cream 1%
- atopic dermatitis control
- quality of life
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