Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
476 participants
INTERVENTIONAL
2013-05-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group A
tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
Treatment Group B
tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
Treatment Group C
placebo ointment (vehicle)
placebo ointment (vehicle) BID (twice daily) for 12 weeks
Treatment Group D
tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
Treatment Group E
tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
Treatment Group F
placebo ointment (vehicle)
placebo ointment (vehicle) QD (once daily) for 12 weeks
Interventions
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tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
placebo ointment (vehicle)
placebo ointment (vehicle) BID (twice daily) for 12 weeks
tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
placebo ointment (vehicle)
placebo ointment (vehicle) QD (once daily) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
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
Menter Dermatology Research Institute
Dallas, Texas, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States
Lee Medical Associates
San Antonio, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Stratica Medical
Edmonton, Alberta, Canada
Dermadvances Research
Winnipeg, Manitoba, Canada
CCA Medical Research Corporation
Ajax, Ontario, Canada
Ultranova Skincare
Barrie, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Siena Medical Research
Montreal, Quebec, Canada
Dermatologisk Afdeling S
Aarhus C, , Denmark
Hudklinikken Herning
Herning, , Denmark
NZOZ Solumed
Poznan, Greater Poland Voivodeship, Poland
Klinika Ambroziak ESTEDERM Sp. z o.o.SKA
Warsaw, Masovian Voivodeship, Poland
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, , Poland
NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych J. Badurski Spolka Jawna
Bialystok, , Poland
Pomorskie Centrum Traumatologii im.Mikolaja Kopernika w Gdansku Oddzial Dermatologii
Gdansk, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Maxxmed Centrum Zdrowia i Urody
Lublin, , Poland
Gabinet Lekarski RTG USG Dr n. med. Pawel Skrzywanek; Pracownia Radiologiczna
Poznan, , Poland
High-Med. Przychodnia Specjalistyczna
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
NZOZ multiMedica
Wroclaw, , Poland
Countries
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References
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Papp KA, Bissonnette R, Gooderham M, Feldman SR, Iversen L, Soung J, Draelos Z, Mamolo C, Purohit V, Wang C, Ports WC. Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial. BMC Dermatol. 2016 Oct 3;16(1):15. doi: 10.1186/s12895-016-0051-4.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2012-005645-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921082
Identifier Type: -
Identifier Source: org_study_id