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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: Pimecrolimus

• Registration Number: NCT00351052
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study Completion: 2004-09
• Study First Submitted: 2006-07-10
• Study First Submitted QC: 2006-07-10
• Study First Posted: 2006-07-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-15
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Vehicle
1	Pimecrolimus	Pimecrolimus

Primary Outcome Measures

Name	Time	Method
Corticoid-sparing effect of pimecrolimus cream 1%

Secondary Outcome Measures

Name	Time	Method
safety of pimecrolimus cream 1%
atopic dermatitis control
quality of life