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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00293917
First received: February 16, 2006
Last updated: February 11, 2008
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Psoriasis
 Drug: Tacrolimus Cream
 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 Phase 3, Long-Term, Open Label Study to Evaluate the Safety of Twice Daily Tacrolimus Cream-B 0.1% in the Treatment of Psoriasis

Resource links provided by NLM:

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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 12 months ]

Enrollment: 658
Study Start Date: January 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293917     History of Changes
Other Study ID Numbers: 04-0-207
Study First Received: February 16, 2006
Last Updated: February 11, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013