Clinical Trial: Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus

Brief Summary: 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

Detailed Summary: 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.
Sponsor: Center for Vulvovaginal Disorders

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Center for Vulvovaginal Disorders

Dates:
Date Received: May 25, 2016
Date Started: May 2014
Date Completion:
Last Updated: June 4, 2016
Last Verified: June 2016