Text Size

A Study to Assess the Safety and Effectiveness 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:
NCT00293891
First received: February 16, 2006
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  Purpose

A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.


Condition Intervention Phase
Psoriasis
 Drug: Tacrolimus Cream
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

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:

Enrollment: 658
Study Completion Date: January 2007
  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 elbows, knees, and scalp
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293891

  Show 33 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Investigators
Study Director: J. Rico, MD Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293891     History of Changes
Other Study ID Numbers: 04-0-206
Study First Received: February 16, 2006
Last Updated: December 19, 2007
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 23, 2013