A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus
Phase 1
Active, not recruiting
- Conditions
- Vulvar Lichen Sclerosus
- Interventions
- Biological: Autologous Platelet-Rich Plasma (PRP)Other: Sham Procedure
- Registration Number
- NCT04967170
- Lead Sponsor
- Jennifer R. Arthurs
- Brief Summary
The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Platelet Rich Plasma Group Autologous Platelet-Rich Plasma (PRP) Subject diagnosed with vulvar lichen sclerosus will receive Autologous Platelet-Rich Plasma (PRP) Sham Procedure Group Sham Procedure Subject diagnosed with vulvar lichen sclerosus will receive sham procedure of intralesional needle insertion without any injectate administered.
- Primary Outcome Measures
Name Time Method Incidence of adverse events 6 months Number of adverse events reported
- Secondary Outcome Measures
Name Time Method Change in patient-administered symptom score on Clinical Scoring System for Lichen Sclerosus Baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months Measured using the self-reported Clinical Scoring System for Lichen Sclerosus questionnaire that scores symptoms from 0 (no complaints) to 10 (extreme complaints)
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States