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

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ClinicalTrials.gov Identifier: NCT00232011
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 17, 2007
Sponsor:
Information provided by:
Novartis

Study Description
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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 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


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus Cream 1% Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 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 Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients
Study Start Date : May 2004
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Pimecrolimus Cream 1%
Pimecrolimus cream 1 %
Other Name: Elidel


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

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

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00232011


Locations
Japan
This study is not being conducted in the United States
Various Cities, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan
More Information
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Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00232011     History of Changes
Other Study ID Numbers: CASM981C1304
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
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
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