Tofacitinib Ointment For Chronic Plaque Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis Vulgaris, Psoriasis

In brief

The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.

Key facts

Study ID

NCT01831466

Run by

Pfizer

People needed

476

Starts

2013-05-01

Expected to finish

2014-09-01

Last updated by the study team

2015-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline
• At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)
• If received certain treatments, should be off treatment for a minimum period of time (washout)

You may not qualify if…

• Currently have non-plaque forms of psoriasis or drug-induced psoriasis
• Require treatment with or cannot stop medication(s) prohibited during the study
• Have certain laboratory abnormalities at Baseline
• Current or history of certain infections
• Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Where it is running

• Bakersfield Dermatology and Skin Cancer Medical Center — Bakersfield, California, United States
• UC Irvine Dermatology Research — Irvine, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Park Avenue Dermatology, PA — Orange Park, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Atlanta Dermatology, Vein & Research Center — Alpharetta, Georgia, United States
• Advanced Medical Research, Inc — Atlanta, Georgia, United States
• MedaPhase Inc. — Newnan, Georgia, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS) — Boston, Massachusetts, United States
• Michigan Center for Skin Care Research — Clinton Township, Michigan, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Radiant Research, Inc. — Cincinnati, Ohio, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Oregon Medical Research Center, PC — Portland, Oregon, United States
• Clinical Partners, LLC — Johnston, Rhode Island, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Radiant Research, Inc. — Greer, South Carolina, United States
• Health Concepts — Rapid City, South Dakota, United States
• Dermatology Research Associates — Nashville, Tennessee, United States
• Arlington Research Center Inc. — Arlington, Texas, United States
• Dermatology Treatment and Research Center — Dallas, Texas, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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