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A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus

NCT04967170 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Vulvar Lichen Sclerosus

Interventions

BIOLOGICAL

Autologous Platelet-Rich Plasma (PRP)

Two intralesional injections of approximately 5-6mL given approximately 6 weeks apart

OTHER

Sham Procedure

Intralesional needle insertion without any injectate.

Sponsors & Collaborators

  • Jennifer R. Arthurs

    lead OTHER

Principal Investigators

  • Katherine Bodiford, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2026-06-01
Completion
2026-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04967170 on ClinicalTrials.gov