What side effects are associated with this type of intervention?

Common treatments for Vulvar Lichen Sclerosus include topical corticosteroids, which can cause skin thinning, irritation, and increased risk of infection with prolonged use. Calcineurin inhibitors like tacrolimus may cause burning, itching, and increased sensitivity to sunlight. For treatments similar to Autologous Platelet-Rich Plasma (PRP), which promotes healing and tissue regeneration, side effects are generally minimal but can include pain at the injection site, infection, and allergic reactions. Overall, PRP is considered safe with a low risk of significant side effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Vulvar Lichen Sclerosus that are similar to autologous platelet-rich plasma (PRP). PRP is an investigational treatment being studied for its potential to promote healing and tissue regeneration through growth factors. Current standard treatments for Vulvar Lichen Sclerosus typically include topical corticosteroids and other immunomodulatory therapies.

What other types of research exist?

Promising novel alternatives to Autologous Platelet-Rich Plasma (PRP) for Vulvar Lichen Sclerosus include cell-based therapies such as fibroblast therapy and genetically modified autologous cultured skin grafts. These therapies aim to promote healing and tissue regeneration through mechanisms similar to PRP.

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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

Must not have

Current tobacco product use, including nicotine patch or other nicotine products

Clinically significant cardiovascular, neurologic, renal, hepatic, or endocrine disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months

Summary

This trial is testing a treatment made from a person's own blood, called platelet-rich plasma (PRP), for women with vulvar lichen sclerosus. This condition affects the skin of the vulva and is often hard to treat. PRP is thought to help by promoting healing and repairing damaged skin. PRP has been used for many years in different medical fields, including cosmetic dermatology.

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.

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.

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 below

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I am using clobetasol cream for Lichen Sclerosus.

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I am not pregnant and agree to use birth control during and for 1 year after the study.

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I have been diagnosed with Lichen Sclerosus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently use tobacco or nicotine products.

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I do not have serious heart, brain, kidney, liver, or hormone-related diseases.

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I have a history of blood disorders such as anemia or low platelet counts.

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I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.

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I am on long-term medication to suppress my immune system.

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I am using topical steroids and cannot stop them for 6 weeks before the study starts.

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I am currently taking blood thinners or clopidogrel.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 6 weeks, 12 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Autologous platelet-rich plasma (PRP) promotes healing and tissue regeneration through the release of growth factors that are essential for cell proliferation and differentiation, and possess anti-inflammatory properties. This mechanism is particularly beneficial for Vulvar Lichen Sclerosus patients, as the condition involves chronic inflammation and tissue damage. By enhancing the body's natural healing processes, PRP can help alleviate symptoms and improve tissue health, offering a promising therapeutic option.