Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Overview

15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period and a 12-week treatment period. Participants will receive two separate treatments of autologous platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection

Full Title of Study: “Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Detailed Description

15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period. A 4mm vulvar punch biopsy will be obtained at the initiation of the screening period to confirm that the participant have active lichen sclerosus. 12 weeks after the biopsy, the participants will receive an injection of 5cc of autologous platelet rich plasma into the affected vulvar skin. Six weeks later, participants will receive an additional injection of 5cc of autologous platelet rich plasma. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection. The inflammation on both biopsy specimens will be determined by a dermatopathologist.

Interventions

  • Biological: Autologous platelet rich plasma
    • 5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.

Arms, Groups and Cohorts

  • Other: Autologous platelet rich plasma
    • Autologous platelet rich plasma injection into vulvar skin. There are no placebo, sham, or active comparator arms

Clinical Trial Outcome Measures

Primary Measures

  • Decrease in inflammation on post treatment biopsies
    • Time Frame: 14 weeks
    • Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies

Secondary Measures

  • Decrease in Pruritus
    • Time Frame: 14 weeks
    • Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching)
  • Investigator Global Assessment
    • Time Frame: 14 weeks
    • The investigator will rate the severity of lichen sclerosus based on the amount of lichenification, fissures, and ulceration. This will be a 4 point scale.

Participating in This Clinical Trial

Inclusion Criteria

  • Active lichen sclerosus – no current treatment – symptomatic 4/10 on visual analogue scale Exclusion Criteria:

  • history of vulvar carcinoma or VIN

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Center for Vulvovaginal Disorders
  • Provider of Information About this Clinical Study
    • Sponsor

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