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

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.

NCT Number	NCT06661382
Lead Sponsor	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions	Vulvar Lichen Sclerosus
Enrollment	100 participants
Start Date	2023-01-24
Primary Completion	2024-11-24 (estimated)
Study Completion	2024-12-24 (estimated)
Updated on ClinicalTrials.gov	2024-10-28