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 |
| 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 May 22, 2013