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Introduction

Lichen sclerosus (LS) is a chronic inflammatory disorder of the anogenital skin. Recent non-controlled studies show that autologous platelet rich plasma (PRP) may be a treatment for LS.

Objective

To determine if PRP is an adequate and safe treatment for LS

Methods

A randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of PRP for the treatment of vulvar LS. Thirty patients (mean age 52.6 years, 29 Caucasians, 1 Hispanic) with biopsy proven active LS were recruited. One participant withdrew after randomization, but before treatment, and 29 completed the study. Patients were randomized to receive either placebo (saline injections) (10 subjects) or two separate treatments of PRP separated by 6 weeks (20 subjects). Each treatment consisted of 5 ml of PRP injected sub-dermally and intra-dermally, infiltrating the areas affected by LS. The PRP was prepared using a FDA cleared, centrifuge which uses a laser to isolate the platelet rich fraction of 60ml of whole blood [Magellan® Autologous Platelet Separator System.] The PRP was collected in a blackened syringe so that neither the physician administering the PRP, nor the study participants, were aware if they were receiving the PRP or placebo. The primary efficacy variable was determined by a pathologist with expertise in vulvar pathology (DH) who was blinded to the treatment arms, who evaluated the inflammatory infiltration on the pre and post treatment biopsies (0 to 3 scale). A secondary endpoint was change in the “Clinical Scoring System for Vulvar Lichen Sclerosus” (CSS) a validated instrument that assesses both the investigators and patients’ impression of the severity of the LS.

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