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OpenTrials
Completed

NCT Number: NCT00231998

Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

This study is not being conducted in the United States

Various Cities, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus

Drug

Pimecrolimus cream 1 %

Other names: Elidel

Primary outcomes

  1. Safety assessed by adverse events (AEs)

Secondary outcomes

  1. Number of flares during 26 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients

Important dates

Study start
2004
Study completion
2005
First posted
Oct 4, 2005
Registry last updated
Dec 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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