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A Phase 2b, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Efficacy, Safety, Local Tolerability And Pharmacokinetics Of 2 Dose Strengths And 2 Regimens Of Tofacitinib Ointment In Subjects With Chronic Plaque Psoriasis.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
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
Start Date
May 1, 2013
Primary Completion Date
September 1, 2014
Completion Date
September 1, 2014
Last Updated
November 25, 2015
476
ACTUAL participants
tofacitinib ointment 20 mg/g
DRUG
tofacitinib ointment 10 mg/g
DRUG
placebo ointment (vehicle)
DRUG
tofacitinib ointment 20 mg/g
DRUG
tofacitinib ointment 10 mg/g
DRUG
placebo ointment (vehicle)
DRUG
Lead Sponsor
Pfizer
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
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