Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Lichen Sclerosus Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Sclerosus
• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

• NCT number: NCT02794363
• Study type: Interventional
• Source: Center for Vulvovaginal Disorders
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Completion date: April 2016