Lichen Sclerosus
Conditions
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.
Interventions
BIOLOGICALAutologous platelet rich plasma
5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.
Sponsors
Center for Vulvovaginal Disorders
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active lichen sclerosus * no current treatment * symptomatic 4/10 on visual analogue scale
Exclusion criteria
* history of vulvar carcinoma or VIN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in inflammation on post treatment biopsies | 14 weeks | Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Pruritus | 14 weeks | Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching) |
| Investigator Global Assessment | 14 weeks | 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. |
Outcome results
None listed