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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: October 3, 2005
Last updated: December 13, 2007
Last verified: December 2007

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00232011     History of Changes
Other Study ID Numbers: CASM981C1304 
Study First Received: October 3, 2005
Last Updated: December 13, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents processed this record on October 25, 2016