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

February 11, 2008 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1R4
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3E1
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1V6
      • Markham, Ontario, Canada, L3P 1AB
      • Windsor, Ontario, Canada, N8W 5L7
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 30322
    • California
      • Fresno, California, United States, 93710
      • Santa Monica, California, United States, 90404
      • Vista, California, United States, 92083
    • Florida
      • Jacksonville, Florida, United States, 32204
      • Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Newnan, Georgia, United States, 30263
    • Idaho
      • Boise, Idaho, United States, 83704
    • Illinois
      • Chicago, Illinois, United States
      • Chicago, Illinois, United States, 60614
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
    • Nevada
      • Reno, Nevada, United States, 89511
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
    • New York
      • East Setauket, New York, United States, 11733
      • New York, New York, United States, 10016
      • New York, New York, United States, 10025
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
    • Texas
      • Arlington, Texas, United States, 76011
      • Houston, Texas, United States, 77056
    • Washington
      • Bellingham, Washington, United States, 98225
      • Kenatchee, Washington, United States, 98801
      • Spokane, Washington, United States, 99202

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 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: 12 months
12 months

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: M 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 Start

January 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 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)

February 13, 2008

Last Update Submitted That Met QC Criteria

February 11, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0-207

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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