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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 24, 2023

Primary Completion Date

November 24, 2024

Study Completion Date

December 24, 2024

Conditions
Vulvar Lichen Sclerosus
Interventions
BIOLOGICAL

Infiltrative 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.

Trial Locations (1)

20122

RECRUITING

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan

All Listed Sponsors
lead

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER