Clinical trial NCT00293917: A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Treatment Outcome
Tacrolimus
Safety
Psoriasis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2006-02-20
Enrollment: 658
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Safety
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Fresno
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Vista
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Lincoln
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: East Windsor
country: United States
state: New Jersey
city: East Setauket
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Hershey
country: United States
state: Pennsylvania
city: Simpsonville
country: United States
state: South Carolina
city: Goodlettsville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Bellingham
country: United States
state: Washington
city: Kenatchee
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Winnipeg
country: Canada
state: Manitoba
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
Study officials:
affiliation: Astellas Pharma US, Inc.
name: M Rico, MD
role: STUDY_DIRECTOR
References: