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Search / Trial NCT06661382

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

Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Oct 25, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for Vulvar Lichen Sclerosus (VLS), a condition that causes severe itching and burning in the vulvar area, often affecting women's quality of life. The study is comparing the effects of Platelet Rich Plasma (PRP) taken from cord blood to a placebo (an inactive treatment) to see if PRP can provide relief from the symptoms of VLS when traditional treatments are not enough.

Women between the ages of 18 and 75 who have been diagnosed with VLS and are in good health may be eligible to participate in the trial. To join, participants must provide written consent and should not be pregnant, have certain blood disorders, or have had recent infections or surgeries in the vulvar area. Those who take part will receive either the PRP treatment or a placebo and will be monitored to see how effective the treatment is. This trial is important because it aims to explore new options for managing a condition that can significantly affect women's lives.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • women with VLS (clinical/histological diagnosis)
  • good health conditions
  • written informed consent signed and dated by the patient
  • Exclusion Criteria:
  • pregnancy
  • coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases
  • ongoing major infections
  • previous vulvar surgery (e.g., lipostructure and/or previous PRP)

About Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is a prestigious research and clinical care institution based in Milan, Italy. Renowned for its commitment to advancing medical knowledge and improving patient outcomes, the foundation integrates cutting-edge research with high-quality healthcare services. It serves as a hub for innovative clinical trials, fostering collaborations among healthcare professionals, researchers, and academic institutions. With a focus on various therapeutic areas, the foundation aims to translate scientific discoveries into effective treatments, ultimately enhancing the quality of life for patients.

Locations

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

veronica Boero, MD

Principal Investigator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported