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A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis

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ClinicalTrials.gov Identifier: NCT00293917
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : February 13, 2008
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc

Brief Summary:
A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

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

Detailed Description:
A long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-B 0.1% in treating the signs and symptoms of psoriasis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-Term, Open Label Study to Evaluate the Safety of Twice Daily Tacrolimus Cream-B 0.1% in the Treatment of Psoriasis
Study Start Date : January 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Tacrolimus




Primary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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 scalp

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): NCT00293917


  Show 37 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
Study Director: M Rico, MD Astellas Pharma US, Inc.

ClinicalTrials.gov Identifier: NCT00293917     History of Changes
Other Study ID Numbers: 04-0-207
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: February 13, 2008
Last Verified: February 2008

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