Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic...
Brief Summary
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”
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Pimecrolimus
- Pimecroliums cream 1 % bid.
- Drug: Placebo
- Vehicle control (placebo) bid.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Pimecrolimus
- Placebo Comparator: 2
- Vehicle
Outcome Measures for this Clinical Trial
Primary Measures
- Corticoid-sparing effect of pimecrolimus cream 1%
Secondary Measures
- atopic dermatitis control
- safety of pimecrolimus cream 1%
- quality of life
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 2 Years
Maximum Age for this Clinical Trial: 18 Years
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis AG Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00351052
Study ID Number: CASM981CDE10
ClinicalTrials.gov Identifier: NCT00351052
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00351052
