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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• women with VLS (clinical/histological diagnosis)

• good health conditions

• written informed consent signed and dated by the patient

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
RECRUITING
Milan
Contact Information
Primary
Veronica Boero, MD
veronica.boero@policlinico.mi.it
0255032318
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2024-12-24
Participants
Target number of participants: 100
Treatments
Experimental: Infiltrative treatment with CB-PRP Group
Placebo_comparator: Placebo infiltrative treatment Group
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov