Topical CP-690,550 For Chronic Plaque Psoriasis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00678561
First received: May 13, 2008
Last updated: November 12, 2010
Last verified: November 2010
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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 (Adult, Senior) |
| 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
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
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:
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 |
| 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 Tofacitinib |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016