Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Pimecrolimus

• Registration Number: NCT00231998
• Lead Sponsor: Novartis

Brief Summary

Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study Completion: 2005-06
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-04
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-13
• Last Update Posted: 2007-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• • Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
• Patients whose guardians have given written informed consent to participation in this study

Exclusion Criteria

• • Patients who failed in treatment compliance in the core study
• Patients who had a major violation of the protocol in the core study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pimecrolimus	-

Primary Outcome Measures

Name	Time	Method
Safety assessed by adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
Number of flares during 26 weeks of treatment

Trial Locations

Locations (1)

This study is not being conducted in the United States; 🇯🇵 Various Cities, Japan