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

NCT ID: NCT00293917

Last Updated: 2008-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

658 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tacrolimus Cream

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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M Rico, MD

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

Site Status

Fresno, California, United States

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Santa Monica, California, United States

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Vista, California, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Newnan, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Lincoln, Nebraska, United States

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Reno, Nevada, United States

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Lebanon, New Hampshire, United States

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East Windsor, New Jersey, United States

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East Setauket, New York, United States

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New York, New York, United States

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New York, New York, United States

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Hershey, Pennsylvania, United States

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Simpsonville, South Carolina, United States

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Goodlettsville, Tennessee, United States

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Arlington, Texas, United States

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Houston, Texas, United States

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Bellingham, Washington, United States

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Kenatchee, Washington, United States

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Spokane, Washington, United States

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Markham, Ontario, Canada

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Windsor, Ontario, Canada

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Countries

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United States Canada

Other Identifiers

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04-0-207

Identifier Type: -

Identifier Source: org_study_id

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