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PRP for Vulvar Lichen Sclerosus
Phase 1 & 2
Recruiting
Led By Katherine Bodiford, MD
Research Sponsored by Jennifer R. Arthurs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On a maintenance regimen of topical clobetasol for Lichen Sclerosus
Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception from the time of screening to a period of 1 year following completion of the drug treatment cycle
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months
Awards & highlights
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.
Who is the study for?
This trial is for women over 18 with Vulvar Lichen Sclerosus who are not pregnant, agree to use contraception, and have been on a maintenance dose of clobetasol. They must understand the study and be willing to follow its rules. Excluded are those with significant health issues like abnormal blood tests, immune suppression, ongoing infections or certain chronic diseases.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of using one's own Platelet-Rich Plasma (PRP) versus a sham procedure to treat Vulvar Lichen Sclerosus. Participants will either receive PRP or undergo a fake procedure without active treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, infection risk from injections, allergic reactions to components in PRP preparation or local anesthetics used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using clobetasol cream for Lichen Sclerosus.
Select...
I am not pregnant and agree to use birth control during and for 1 year after the study.
Select...
I have been diagnosed with Lichen Sclerosus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Change in patient-administered symptom score on Clinical Scoring System for Lichen Sclerosus
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet Rich Plasma GroupExperimental Treatment1 Intervention
Subject diagnosed with vulvar lichen sclerosus will receive Autologous Platelet-Rich Plasma (PRP)
Group II: Sham Procedure GroupPlacebo Group1 Intervention
Subject diagnosed with vulvar lichen sclerosus will receive sham procedure of intralesional needle insertion without any injectate administered.
Find a Location
Who is running the clinical trial?
Jennifer R. ArthursLead Sponsor
Katherine Bodiford, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently use tobacco or nicotine products.I am a woman aged 18 or older.Criterion: Women who get pregnant during the study will be closely watched and any serious events related to the pregnancy will be recorded.I have had a physical check-up within the last year.I do not have serious heart, brain, kidney, liver, or hormone-related diseases.I haven't had cancer in the last 5 years, except for certain skin cancers.You have a history of alcohol or drug abuse, or have used recreational drugs or prescription medications for non-medical reasons within the last 30 days.I am using clobetasol cream for Lichen Sclerosus.I have a history of blood disorders such as anemia or low platelet counts.I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.You are allergic to the numbing medicine or other parts of the study drug.I am not pregnant, can use birth control, and agree to do so during and for 1 year after treatment.I am a woman aged 18 or older.I am not pregnant and agree to use birth control during and for 1 year after the study.I have been diagnosed with Lichen Sclerosus.I use clobetasol cream for Lichen Sclerosus up to 3 times a week.I am fully aware of the requirements of the study and I am willing to comply with the protocol.You have a significant problem with your blood.I am on long-term medication to suppress my immune system.I have taken medication for rheumatic disease in the last 3 months.I am using topical steroids and cannot stop them for 6 weeks before the study starts.I have seen my primary care doctor for a check-up within the last year.I am currently taking blood thinners or clopidogrel.
Research Study Groups:
This trial has the following groups:- Group 1: Platelet Rich Plasma Group
- Group 2: Sham Procedure Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Vulvar Lichen Sclerosus Patient Testimony for trial: Trial Name: NCT04967170 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently enrolled in this research trial?
"Affirmative. Clinicaltrials.gov's data mentions that this investigation is actively seeking participants, which began on 11/4/2021 and was recently updated on 5/23/2022. 60 individuals are necessary to be sourced from a single medical centre for the trial."
Answered by AI
Are there still openings for participation in the current trial?
"Affirmative, the portal on clinicaltrials.gov shows that this scientific inquiry is actively recruiting individuals to participate. The study was initially shared on November 4th 2021 and last changed May 23rd 2022 - with a requirement of 60 enrollees from 1 location."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Tennessee
Maine
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I want to help find a cure for this miserable disease! This disease has been life altering for my family and I! No one should have to live with this much pain and discomfort. The Lichen Sclerosis community needs a cure! I am willing to get in my car and drive to Jacksonville today!
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is the trail?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Mayo Clinic in Florida: < 48 hours
Average response time
- < 2 Days
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