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A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis

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.
ClinicalTrials.gov Identifier: NCT00293930
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : December 24, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Tacrolimus Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Tacrolimus
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

  • Skin disorder other than plaque psoriasis in the areas to be treated.
  • Disease on only elbows, knees, and scalp
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): NCT00293930


  Show 32 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
Study Director: J Rico, MD Astellas Pharma US, Inc.
More Information

ClinicalTrials.gov Identifier: NCT00293930     History of Changes
Other Study ID Numbers: 04-0-205
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Astellas Pharma Inc:
Treatment Outcome
Tacrolimus
Safety
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action