Topical CP-690,550 For Chronic Plaque Psoriasis - Full Text View

Purpose

Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.

Condition	Intervention	Phase
Psoriasis	Drug: CP-690,550 Drug: Placebo Vehicle	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Phase 2A Randomized, Double-Blind, Vehicle-Controlled, Intra-Individual Comparison Trial Assessing Safety, Toleration, Pharmacokinetics And Pilot Efficacy Of 4 Weeks Treatment With Topical CP-690,550 In Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

target plaque severity score [ Time Frame: 4 weeks ]

Secondary Outcome Measures:

local toleration [ Time Frame: 4 weeks ]
safety laboratory assays [ Time Frame: 4 weeks ]
blood levels of drug [ Time Frame: 4 weeks ]
physician's global assessment of target lesion [ Time Frame: 4 weeks ]


Enrollment:	81
Study Start Date:	October 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2% CP-690,550 QD	Drug: CP-690,550 Topical treatment once daily for 28 days
Experimental: 0.2% CP-690,550 QD	Drug: CP-690,550 Topical treatment once daily for 28 days
Experimental: 0.02% CP-690,550 QD	Drug: CP-690,550 Topical treatment once daily for 28 days
Experimental: 2% CP-690,550 BID	Drug: CP-690,550 Topical treatment twice daily for 28 days
Experimental: 0.2% CP-690,550 BID	Drug: CP-690,550 Topical treatment twice daily for 28 days
Experimental: 0.02% CP-690,550 BID	Drug: CP-690,550 Topical treatment twice daily for 28 days
Placebo Comparator: Placebo Vehicle QD	Drug: Placebo Vehicle Topical treatment once daily for 28 days
Placebo Comparator: Placebo Vehicle BID	Drug: Placebo Vehicle Topical treatment twice daily for 28 days

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Having chronic plaque psoriasis for at least 6 months
Able to withdraw all prior psoriasis treatments
Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

Exclusion Criteria:

Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
Pregnant or lactating women
Unwilling to use appropriate contraceptive methods

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678561

Locations


United States, California
Pfizer Investigational Site
Irvine, California, United States, 92697
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109-0314
United States, Minnesota
Pfizer Investigational Site
Fridley, Minnesota, United States, 55432-3134
United States, Missouri
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63117
United States, North Carolina
Pfizer Investigational Site
High Point, North Carolina, United States, 27262
Pfizer Investigational Site
WinstoN Salem, North Carolina, United States, 27157
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97223
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78759
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
Canada, British Columbia
Pfizer Investigational Site
Surrey, British Columbia, Canada, V3R 6A7
Canada, Newfoundland and Labrador
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Ontario
Pfizer Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Pfizer Investigational Site
Montreal, Quebec, Canada, H3Z 2S6
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4X7

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ports WC, Feldman SR, Gupta P, Tan H, Johnson TR, Bissonnette R. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design. J Drugs Dermatol. 2015 Aug;14(8):777-84.


Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00678561 History of Changes
Other Study ID Numbers:	A3921038
Study First Received:	May 13, 2008
Last Updated:	November 12, 2010

Keywords provided by Pfizer:


chronic plaque psoriasis, topical treatment

Additional relevant MeSH terms:


Psoriasis Skin Diseases, Papulosquamous Skin Diseases Tofacitinib	Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017