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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
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
NCT00293930
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
November 2006 (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
645 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tacrolimus

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