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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by (Responsible Party): | John Koo, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00678470 |
Purpose
This is a single-center, open-label, pilot study. A total of 20 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 3 and an induration score greater than 1 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 |
|---|---|
|
Moderate to Severe Psoriasis |
Drug: Intralesional Alefacept |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Arm, Open Label Study to Explore if Response to Intralesional Alefacept Injections Prior to the Standard Course of Intramuscular Treatment Can Predict Clinical Outcomes in Patients With Moderate to Severe Chronic Plaque Psoriasis |
| Enrollment: | 20 |
| Study Start Date: | September 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm
Investigational intervention without random assignment
|
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.
Other Name: Amevive
|
See Brief Summary
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF Psoriasis and Skin Treatment Center | |
| San Francisco, California, United States, 94118 | |
| Principal Investigator: | John Koo, MD | UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco |
More Information
| Responsible Party: | John Koo, Principle Investigator, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00678470 History of Changes |
| Other Study ID Numbers: | KOO-AMEVIVE-2008, CHR-H5939-31199-01 |
| Study First Received: | May 13, 2008 |
| Last Updated: | January 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Alefacept |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions |