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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

• Corticoid-sparing effect of pimecrolimus cream 1%

Secondary Measures

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

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

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis AG Study Chair Novartis  

Information obtained from ClinicalTrials.gov on October 06, 2008

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