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

December 19, 2007 updated by: Astellas Pharma Inc
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

645

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 4S8
    • Ontario
      • North Bay, Ontario, Canada, P1B 3Z7
      • Waterloo, Ontario, Canada, N2J 1C4
      • Windsor, Ontario, Canada, N8W 1E6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • San Diego, California, United States, 92117
      • San Fransisco, California, United States, 94118
    • Colorado
      • Longmont, Colorado, United States, 80501
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Miami, Florida, United States, 33175
    • Georgia
      • Newnan, Georgia, United States, 30263
    • Indiana
      • Evansville, Indiana, United States, 47713
      • South Bend, Indiana, United States, 46617
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Missouri
      • St. Louis, Missouri, United States, 63117
    • New York
      • New York, New York, United States, 10029
      • Rochester, New York, United States, 14623
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Bryan, Texas, United States, 77802
      • Dallas, Texas, United States, 75230
      • Galveston, Texas, United States, 77555
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Lynchburg, Virginia, United States, 24501
    • Washington
      • Dayton, Washington, United States, 99328
    • Wisconsin
      • Madison, Wisconsin, United States, 53719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Study Director: J Rico, MD, Astellas Pharma US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 24, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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