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A Study to Assess the Safety and Effectiveness 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
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Treatment Outcome, Tacrolimus, Safety, Psoriasis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 16, 2006
Last Updated
December 19, 2007
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00293891
Brief Title
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.

4. Oversight

5. Study Description

Brief Summary
A study to assess the safety and effectiveness of tacrolimus cream in the treatment 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
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
658 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tacrolimus Cream

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 elbows, knees, and scalp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Rico, MD
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
City
N. Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
City
New York City
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R
Country
Canada
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7S 2C6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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