Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

Phase 3CompletedNCT00231998

Novartis240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Atopic Dermatitis

Interventions

PimecrolimusDRUG

Pimecrolimus cream 1 %

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

This study is not being conducted in the United States

Various Cities, Japan

Outcomes

Primary Outcomes

Safety assessed by adverse events (AEs)

Secondary Outcomes

Number of flares during 26 weeks of treatment

Data from ClinicalTrials.gov

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