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)

658

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

    • Alberta
      • Calgary, Alberta, Canada, T2S 3B3
      • Edmonton, Alberta, Canada, T5J 3S9
    • British Columbia
      • Surrey, British Columbia, Canada, V3R
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
    • Quebec
      • Laval, Quebec, Canada, H7S 2C6
      • Montreal, Quebec, Canada, H2K 4L5
    • Alabama
      • Birmingham, Alabama, United States, 35205
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • San Diego, California, United States, 92123
    • Colorado
      • Denver, Colorado, United States, 80246
    • Florida
      • Miami, Florida, United States, 33144
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Newnan, Georgia, United States, 30263
    • Indiana
      • Indianapolis, Indiana, United States, 46256
    • Kentucky
      • Louisville, Kentucky, United States, 40217
    • Massachusetts
      • N. Andover, Massachusetts, United States, 01845
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Port Huron, Michigan, United States, 48060
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • New York
      • New York City, New York, United States, 10032
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Columbus, Ohio, United States, 43212
      • Dayton, Ohio, United States, 45408
    • Oregon
      • Portland, Oregon, United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77058
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Seattle, Washington, United States, 98101
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209

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.

Collaborators

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)

January 1, 2007

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

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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