Autologous Platelet-Rich Plasma (PRP) for Vulvar Lichen Sclerosus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vulvar Lichen Sclerosus+1 More
Autologous Platelet-Rich Plasma (PRP) - Biological
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will test whether a person's own platelets can help treat vulvar lichen sclerosus, a painful and itchy condition. Safety and effectiveness will be studied.

Eligible Conditions
  • Vulvar Lichen Sclerosus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months

6 months
Incidence of adverse events
Month 6
Change in patient-administered symptom score on Clinical Scoring System for Lichen Sclerosus

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Platelet Rich Plasma Group
1 of 2
Sham Procedure Group
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Autologous Platelet-Rich Plasma (PRP) · Has Placebo Group · Phase 1 & 2

Platelet Rich Plasma Group
Biological
Experimental Group · 1 Intervention: Autologous Platelet-Rich Plasma (PRP) · Intervention Types: Biological
Sham Procedure Group
Other
ShamComparator Group · 1 Intervention: Sham Procedure · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months

Who is running the clinical trial?

Jennifer R. ArthursLead Sponsor
Katherine Bodiford, MDPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · Female Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The diagnosis of lichen sclerosus is based on the patient's symptoms, physical examination, and laboratory tests.
If you have been recently diagnosed with Lichen Sclerosus, you will need to use clobetasol ointment twice a day for 6 weeks before you can take part in this study
Completed a general physical evaluation with a primary care provider within the past 12 months.
I am fully aware of the requirements of the study and I am willing to comply with the protocol.
If a female participant becomes pregnant during the study, she will be monitored until the end of the study or until she delivers the baby, whichever is longer
The person can write down that they agree to take part in the study, and they can also fill out paperwork indicating that they know and agree to the terms of the study
This phrase refers to any female who is at least 18 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Pennsylvania50.0%
Maine50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Mayo Clinic in Florida100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. Mayo Clinic in Florida: < 48 hours
Typically responds via
Email100.0%
Average response time
  • < 2 Days