RecruitingPhase 1Phase 2NCT06661382

Use of Platelet Rich Plasma from Cord Blood Vs Placebo in the Treatment of Vulvar Lichen Sclerosus


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

100 participants

Start Date

Jan 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Vulvar lichen Sclerosus (VLS) is a cutaneous-mucosal dermatosis that causes in the adult female vulvar itching and burning due to scratching abrasions. Dyspareunia is often associated . The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of VLS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such as regenerative medicine. The term PRP (Platelet Rich Plasma) is used to describe a blood product generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. PRP can be produced from autologous, homologous blood or from cord blood (CB-PRP). Our objective is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Infiltrative treatment with CB-PRP for people with vulvar lichen sclerosus. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALInfiltrative treatment with CB-PRP

Injection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP/ placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function.


Locations(1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Milan, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06661382


Related Trials