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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00678470 |
This is a single-center, open-label, pilot study. A total of 9 subjects will be enrolled in this 6 month study to evaluate whether the response to intralesional alefacept injections prior to the standard course of intramuscularly (IM) treatment can predict clinical outcomes in psoriasis patients. Three lesions with a psoriasis severity assessment score greater than 6 and an induration score greater than 2 will be identified on each patient. Each lesion will receive only one intralesional alefacept injection during the first three weeks of the study (1 lesion per week). The concentration of the alefacept's injections will be increased over the three weeks to avoid severe injection site reactions as well as to determine the most effective intralesional dose. The psoriasis severity assessment score will be used to evaluate the lesion's response to the injections. Following a 2 week observation period, subjects will undergo a standard 12 week course of weekly intramuscular alefacept injections. The Psoriasis Area Severity Index (PASI) score will be used to determine the effectiveness of the intramuscular alefacept treatments. An 8 week follow-up period will begin after the last dose of alefacept is administered where safety and efficacy measures will continue to be monitored as outlined in the study procedures. The hypothesis is that the response to intralesional alefacept injections, whether it is positive or no benefit, will predict the clinical response to intramuscular alefacept administration.
Condition | Intervention |
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Moderate to Severe Psoriasis |
Drug: Intralesional Alefacept |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Single Arm, Open Label Study to Explore if Response to Intralesional Alefacept Injections Prior to the Standard Course of Intramuscularly (IM) Treatment Can Predict Clinical Outcomes in Patients With Moderate to Severe Chronic Plaque Psoriasis |
Estimated Enrollment: | 9 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Arm: Experimental
Investigational intervention without random assignment
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Drug: Intralesional Alefacept
Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: John Koo, MD | 4154764701 | john.koo@ucsfmedctr.org |
Contact: Thao U Nguyen, BS | 6786437796 | thao.u.nguyen@gmail.com |
United States, California | |
UCSF Psoriasis and Skin Treatment Center | Recruiting |
San Francisco, California, United States, 94118 | |
Contact: John Koo, MD 415-476-4701 john.koo@ucsfmedctr.org | |
Contact: Thao Nguyen, BS 6786437796 thao.u.nguyen@gmail.com | |
Sub-Investigator: Thao Nguyen, BS | |
Principal Investigator: John Koo, MD |
Principal Investigator: | John Koo, MD | UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco |
Responsible Party: | University of California San Francisco ( John Koo, M.D. ) |
Study ID Numbers: | KOO-AMEVIVE-2008, CHR-H5939-31199-01 |
Study First Received: | May 13, 2008 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00678470 |
Health Authority: | United States: Food and Drug Administration |
Alefacept Skin Diseases Psoriasis Skin Diseases, Papulosquamous |
Therapeutic Uses Dermatologic Agents Pharmacologic Actions |