Actively Recruiting
Use of Platelet Rich Plasma from Cord Blood Vs Placebo in the Treatment of Vulvar Lichen Sclerosus
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-10-28
100
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Platelet Rich Plasma from Cord Blood Vs Placebo in the Treatment of Vulvar Lichen Sclerosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with clinically or histologically diagnosed vulvar lichen sclerosus
- In good health condition
- Signed and dated written informed consent
You will not qualify if you...
- Pregnancy
- Coagulopathies, platelet disorders, cardiovascular or respiratory diseases
- Active major infections
- Previous vulvar surgery such as lipostructure or prior PRP treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Milan, Italy, 20122
Actively Recruiting
Research Team
V
Veronica Boero, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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