Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00231998
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 17, 2007
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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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients
Study Start Date : May 2004
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel

Primary Outcome Measures :
  1. Safety assessed by adverse events (AEs)

Secondary Outcome Measures :
  1. Number of flares during 26 weeks of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00231998

This study is not being conducted in the United States
Various Cities, Japan
Sponsors and Collaborators
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan

Responsible Party: External Affairs, Novartis Identifier: NCT00231998     History of Changes
Other Study ID Numbers: CASM981C1302
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: December 17, 2007
Last Verified: December 2007

Keywords provided by Novartis:
Atopic dermatitis, ASM981, pimecrolimus

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action