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

This study has been completed.

First Received: February 16, 2006 Last Updated: February 11, 2008 History of Changes

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00293917

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: Tacrolimus Cream	Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Safety [ Time Frame: 12 months ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 12 months ]

Enrollment:	658
Study Start Date:	January 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293917

Show 37 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma US, Inc.

Investigators

Study Director:

M Rico, MD

Astellas Pharma US, Inc.

More Information

No publications provided

Study ID Numbers:	04-0-207
Study First Received:	February 16, 2006
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00293917 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

Treatment Outcome
Tacrolimus
Safety
Psoriasis

Study placed in the following topic categories:

Immunologic Factors
Skin Diseases
Psoriasis

Tacrolimus
Immunosuppressive Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Immunologic Factors
Skin Diseases
Psoriasis
Physiological Effects of Drugs

Tacrolimus
Immunosuppressive Agents
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009