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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 4, 2005
Last Update Posted: December 17, 2007
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.
Information provided by:

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.


Condition Intervention Phase
Atopic Dermatitis Drug: Pimecrolimus Cream 1% Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 160
Study Start Date: May 2004
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: 1 Drug: Pimecrolimus Cream 1%
Pimecrolimus cream 1 %
Other Name: Elidel


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
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 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
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

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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00232011     History of Changes
Other Study ID Numbers: CASM981C1304
First Submitted: October 3, 2005
First Posted: October 4, 2005
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