PRP for Vulvar Lichen Sclerosus

Overseen By Stephanie McNew

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Jennifer R. Arthurs

Must be taking: Topical clobetasol

Must not be taking: Anticoagulants, Antirheumatics, Immunosuppressants

Disqualifiers: Pregnancy, Tobacco use, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using topical steroids on the affected area for a 6-week period before starting the study and throughout the first 12 weeks if you receive PRP. Additionally, you cannot participate if you are taking anticoagulant medications, anti-rheumatic drugs, or are on chronic immunosuppressive therapy.

What data supports the effectiveness of the treatment Autologous Platelet-Rich Plasma (PRP) for Vulvar Lichen Sclerosus?

Research shows that PRP injections can help repair tissue and improve symptoms in people with vulvar lichen sclerosus, as seen in a study where a woman experienced significant symptom relief and tissue improvement after PRP treatment. Another study also reported positive effects on tissue repair and symptom scores in patients with this condition. ^{1 2 3 4 5}

Is platelet-rich plasma (PRP) safe for treating vulvar lichen sclerosus?

Research on platelet-rich plasma (PRP) for conditions like vulvar lichen sclerosus suggests it may help with tissue repair and symptom relief, and no significant safety issues have been reported in the studies available. ^{1 2 4 5 6}

How does the treatment PRP differ from other treatments for vulvar lichen sclerosus?

PRP (platelet-rich plasma) is unique because it uses a patient's own blood components to promote tissue repair and regeneration, unlike the standard treatment of topical corticosteroids, which primarily reduce inflammation. PRP is administered through injections directly into the affected area, offering a potential new option for those who do not respond well to traditional treatments. ^{1 2 3 4 6}

Research Team

Katherine Bodiford, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I currently use tobacco or nicotine products.

Participation in a study of an experimental drug or medical device within 3 months of study enrollment

Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either autologous platelet-rich plasma or a sham procedure for the treatment of vulvar lichen sclerosus

12 weeks

Baseline, 1 week, 6 weeks, 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Autologous Platelet-Rich Plasma (PRP)
• Sham Procedure

Trial Overview 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.

Participant Groups

Group I: Platelet Rich Plasma Group Experimental Treatment 1 Intervention

Subject diagnosed with vulvar lichen sclerosus will receive Autologous Platelet-Rich Plasma (PRP)

Group II: Sham Procedure Group Placebo Group 1 Intervention

Subject diagnosed with vulvar lichen sclerosus will receive sham procedure of intralesional needle insertion without any injectate administered.

Who Is Running the Clinical Trial?

Jennifer R. Arthurs

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

Platelet-rich plasma (PRP) treatment for lichen sclerosus showed subjective improvements in quality of life, but objective evidence of its effectiveness was lacking based on a systematic review of eight studies.

The studies reviewed highlighted a lack of standardization in PRP preparation and administration, indicating a need for more controlled trials to accurately assess its efficacy as a treatment for lichen sclerosus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma for the treatment of lichen sclerosus. Villalpando, BK., Wyles, SP., Schaefer, LA., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Mid-term symptomatic relief after platelet-rich plasma infiltration in vulvar lichen sclerosus. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma (PRP) for the treatment of vulvar lichen sclerosus in a premenopausal woman: A case report. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma for the treatment of lichen sclerosus. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Fact or Fiction? Adipose-Derived Stem Cells and Platelet-Rich Plasma for the Treatment of Vulvar Lichen Sclerosus. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma (PRP) in chronic penile lichen sclerosus: the impact on tissue repair and patient quality of life. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Use of Platelet-rich Plasma for Vulvovaginal Autoimmune Conditions Like Lichen Sclerosus. [2020]