Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.
The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up. At those visits, the patient can expect that a physical and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin will be taken.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
Rockefeller University
New York, New York, United States
The Rockefeller University
New York, New York, United States
Number of Participants With Clinical Improvement of Target Lesions
a single composite score based on quantitative measurement of epidermal acanthosis, qualitative expression of Keratin16 (histochemistry assessment) and quantitative measurement of K16 mRNA.
Time frame: week 12
Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI)
Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Clinical response defined as PASI improvement over 75% at week 12.
Time frame: Day 0, day 14, day 42, day 84, Days 112, 140, and 168. PASI has been measured at those timepoints but outcome is related to Baseline and Day 84.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.