Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lichen Sclerosus

Intervention / Treatment
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* Biological: Autologous platelet rich plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active lichen sclerosus no current treatment symptomatic 4/10 on visual analogue scale Exclusion Criteria: history of vulvar carcinoma or VIN

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Autologous platelet rich plasma<br>Autologous platelet rich plasma injection into vulvar skin. There are no placebo, sham, or active comparator arms | Biological: Autologous platelet rich plasma<br>* 5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in inflammation on post treatment biopsies | Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Pruritus | Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching) | 14 weeks | 
| Investigator Global Assessment | 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. | 14 weeks |