Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

Novartis

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Pimecrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231998

CASM981C1302

Details and patient eligibility

About

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

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Pimecrolimus