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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00678561

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 II

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

target plaque severity score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

local toleration [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
safety laboratory assays [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
blood levels of drug [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
physician's global assessment of target lesion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, Illinois
Pfizer Investigational Site	Recruiting
Chicago, Illinois, United States, 60612
United States, Michigan
Pfizer Investigational Site	Recruiting
Ann Arbor, Michigan, United States, 48109-0314
United States, Minnesota
Pfizer Investigational Site	Recruiting
Fridley, Minnesota, United States, 55432-3134
United States, Missouri
Pfizer Investigational Site	Recruiting
Saint Louis, Missouri, United States, 63117
United States, North Carolina
Pfizer Investigational Site	Recruiting
WinstoN Salem, North Carolina, United States, 27157
United States, Oregon
Pfizer Investigational Site	Recruiting
Portland, Oregon, United States, 97223
Pfizer Investigational Site	Recruiting
Portland, Oregon, United States, 97239
United States, Utah
Pfizer Investigational Site	Not yet recruiting
Salt Lake City, Utah, United States, 84132
Canada
Pfizer Investigational Site	Recruiting
Quebec, Canada, G1V 4X7
Canada, Ontario
Pfizer Investigational Site	Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Pfizer Investigational Site	Recruiting
Montreal, Quebec, Canada, H2K 4L5

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921038
Study First Received:	May 13, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00678561
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

chronic plaque psoriasis, topical treatment

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 15, 2009