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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called autologous platelet-rich plasma (PRP) to determine its safety and effectiveness for managing vulvar lichen sclerosus, a skin condition causing itching and discomfort in the vulva area. Participants will receive either the PRP treatment or a sham procedure that mimics the treatment without the active ingredient. Women diagnosed with vulvar lichen sclerosus and currently using topical clobetasol (a steroid ointment) three days or fewer per week may be suitable for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to the early-stage development of a potentially beneficial treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using one's own platelet-rich plasma (PRP) is generally safe. Most studies have found a very low risk of serious side effects, such as scar tissue or other major issues. Some mild side effects, like temporary swelling or redness, might occur, but they are usually not serious. Overall, previous research suggests that PRP is safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for vulvar lichen sclerosus, which often involve topical steroids, Autologous Platelet-Rich Plasma (PRP) offers a novel approach by utilizing the patient's own blood components to promote healing. Researchers are excited about PRP because it harnesses growth factors found in platelets to potentially regenerate and repair affected tissues. This treatment could offer a more natural and potentially longer-lasting solution compared to traditional options, which usually focus on managing symptoms rather than healing the underlying condition.

What evidence suggests that autologous platelet-rich plasma might be an effective treatment for vulvar lichen sclerosus?

Research has shown that using a person's own platelet-rich plasma (PRP) might help treat vulvar lichen sclerosus. In this trial, participants in the Platelet Rich Plasma Group will receive PRP treatment. Studies have found that PRP can improve patients' lives by easing symptoms. It also reduces swelling in the affected skin, a major issue with this condition. Although more information is still being gathered, early results suggest that PRP aids in healing and tissue repair. Overall, these findings indicate that PRP could be a useful treatment for managing vulvar lichen sclerosus. ^{1 2 3 6 7}

Who Is on the Research Team?

Katherine Bodiford, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8694569/

Platelet-rich plasma for the treatment of lichen sclerosus - PMC Using validated questionnaires, 3 studies reported PRP improved patient quality of life. Posey et al. reported the utilization of a patient questionnaire but ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03045172

Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus This will be a randomized single-blind placebo controlled trial to evaluate the efficacy and safety of autologous Platelet-rich Plasma (PRP) for the treatment ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40902148/

Platelet-Rich Plasma Versus Saline for the Treatment of ... Conclusions: This study will evaluate the safety and efficacy of PRP injections compared to those of saline injections for the treatment of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214911218300250

Platelet-rich plasma (PRP) for the treatment of vulvar lichen ... In conclusion, our case highlights that PRP seems a promising new treatment for female genital LS, as it promotes regeneration and leads to cessation of ...

5. jaad.org jaad.org/article/s0190-9622(16)30588-6/fulltext

Intradermal injection of autologous platelet-rich plasma for ... However, the statistically significant results suggest that PRP decreased histopathologic inflammation in women with VLS without the potential side effects ...

6. researchprotocols.org researchprotocols.org/2025/1/e68871

Platelet-Rich Plasma Versus Saline for the Treatment of ... LS is associated with decreased quality of life and increased risk of vulvar neoplasia. Alternatives to current treatments are highly desired by ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10671587/

Platelet-Rich Plasma (PRP) and Adipose-Derived Stem ... The use of PRP and ADSC therapy for genital lichen sclerosus represents a promising and safe treatment modality. These regenerative approaches ...