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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.
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc Identifier:
First received: February 16, 2006
Last updated: February 11, 2008
Last verified: February 2008
A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

Condition Intervention Phase
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:

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.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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: NCT00293917

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

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016