NCT00293917

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
658

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
2 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 13, 2008

Status Verified

February 1, 2008

Enrollment Period

1.6 years

First QC Date

February 16, 2006

Last Update Submit

February 11, 2008

Conditions

Psoriasis

Keywords

Treatment OutcomeTacrolimusSafetyPsoriasis

Outcome Measures

Primary Outcomes (1)

  • Safety

    12 months

Secondary Outcomes (1)

  • Efficacy

    12 months

Interventions

Tacrolimus CreamDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of plaque psoriasis

You may not qualify if:

  • Skin disorder other than plaque psoriasis in the areas to be treated.
  • Disease on only scalp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Unknown Facility

Birmingham, Alabama, 30322, United States

Location

Unknown Facility

Fresno, California, 93710, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Vista, California, 92083, United States

Location

Unknown Facility

Jacksonville, Florida, 32204, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Newnan, Georgia, 30263, United States

Location

Unknown Facility

Boise, Idaho, 83704, United States

Location

Unknown Facility

Chicago, Illinois, 60614, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

New Orleans, Louisiana, 70112, United States

Location

Unknown Facility

Boston, Massachusetts, 02118, United States

Location

Unknown Facility

Detroit, Michigan, 48202, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

Lincoln, Nebraska, 68502, United States

Location

Unknown Facility

Reno, Nevada, 89511, United States

Location

Unknown Facility

Lebanon, New Hampshire, 03756, United States

Location

Unknown Facility

East Windsor, New Jersey, 08520, United States

Location

Unknown Facility

East Setauket, New York, 11733, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

New York, New York, 10025, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Simpsonville, South Carolina, 29681, United States

Location

Unknown Facility

Goodlettsville, Tennessee, 37072, United States

Location

Unknown Facility

Arlington, Texas, 76011, United States

Location

Unknown Facility

Houston, Texas, 77056, United States

Location

Unknown Facility

Bellingham, Washington, 98225, United States

Location

Unknown Facility

Kenatchee, Washington, 98801, United States

Location

Unknown Facility

Spokane, Washington, 99202, United States

Location

Unknown Facility

Winnipeg, Manitoba, R3C 1R4, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 1V6, Canada

Location

Unknown Facility

Markham, Ontario, L3P 1AB, Canada

Location

Unknown Facility

Windsor, Ontario, N8W 5L7, Canada

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • M Rico, MD

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 13, 2008

Record last verified: 2008-02

Locations

US(31)CA(6)