Back to resultsA Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tacrolimus Cream
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Treatment Outcome, Tacrolimus, Safety, Psoriasis
Eligibility 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 scalp
Sites / Locations
Outcomes
Primary Outcome Measures
Safety
Secondary Outcome Measures
Efficacy
Full Information
NCT ID
NCT00293917
First Posted
February 16, 2006
Last Updated
February 11, 2008
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00293917
Brief Title
A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Treatment Outcome, Tacrolimus, Safety, Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
658 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tacrolimus Cream
Primary Outcome Measure Information:
Title
Safety
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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 scalp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Rico, MD
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
30322
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
City
Kenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1R4
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z4
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1AB
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis
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