Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

NCT ID: NCT02794363

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-04-30

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous platelet rich plasma

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

Group Type: OTHER

Autologous platelet rich plasma

Intervention Type: BIOLOGICAL

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

Interventions

Autologous platelet rich plasma

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• history of vulvar carcinoma or VIN

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Center for Vulvovaginal Disorders

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

604763-1

Identifier Type: -

Identifier Source: org_study_id