Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Center for Vulvovaginal Disorders

Status: Completed

Conditions: Lichen Sclerosus

Treatments: Biological: Autologous platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02794363

604763-1

Details and patient eligibility

About

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 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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active lichen sclerosus
• no current treatment
• symptomatic 4/10 on visual analogue scale

Exclusion criteria

• history of vulvar carcinoma or VIN

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Autologous platelet rich plasma

Other group

Description:

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

Treatment:

Biological: Autologous platelet rich plasma