NCT02794363

Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Center for Vulvovaginal Disorders · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Lichen Sclerosus

Interventions

Type	Name	Description
BIOLOGICAL	Autologous platelet rich plasma	5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2016-06-09
• Last updated: 2016-06-09