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Topical CP-690,550 For Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00678561
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
Pfizer

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Drug: CP-690,550 Drug: Placebo Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : October 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. target plaque severity score [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. local toleration [ Time Frame: 4 weeks ]
  2. safety laboratory assays [ Time Frame: 4 weeks ]
  3. blood levels of drug [ Time Frame: 4 weeks ]
  4. physician's global assessment of target lesion [ Time Frame: 4 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00678561     History of Changes
Other Study ID Numbers: A3921038
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 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