Topical CP-690,550 For Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00678561
First received: May 13, 2008
Last updated: November 12, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


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 ]

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
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

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:
No publications provided

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
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chronic plaque psoriasis, topical treatment

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014