Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis

Phase 3CompletedNCT00232011

Novartis160 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 adult 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

160

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus Cream 1%DRUG

Pimecrolimus cream 1 %

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 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 who had 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 disease flares during 26 weeks of treatment

Data from ClinicalTrials.gov

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