Actively Recruiting
Use of Platelet Rich Plasma from Cord Blood Versus 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Vulvar Lichen Sclerosus (VLS) is a skin and mucous membrane condition that mainly affects adult women, causing itching, burning, and discomfort in the vulvar area. This condition often leads to painful sexual intercourse and impacts quality of life. Traditional treatment with high potency topical corticosteroids may not always be enough, so researchers are exploring new options like regenerative medicine to improve symptoms and tissue health. This trial evaluates the use of Platelet Rich Plasma from cord blood (CB-PRP) compared to a placebo. CB-PRP is a blood product concentrated with platelets and growth factors that promote healing, prepared through a two-step centrifugation process. The treatment involves three injections into the vulvar area spaced four weeks apart, followed by re-evaluations at three and six months after the last injection using vulvoscopy, biopsy, and questionnaires. Participants will be monitored through medical examinations, tissue biopsies, and validated questionnaires assessing patient satisfaction, symptom changes, mucosal health, sexual activity, and quality of life over three and six months. The main outcome focuses on patient satisfaction at three months. The study is randomized and triple-masked, with follow-ups designed to closely observe treatment effects and safety over time.
CONDITIONS
Brief 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 a clinical or histological diagnosis of Vulvar Lichen Sclerosus
- Good overall health condition
- Signed and dated written informed consent
You will not qualify if you...
- Pregnancy
- Blood clotting disorders, platelet problems, cardiovascular or respiratory diseases
- Ongoing major infections
- Previous vulvar surgery such as lipostructure or prior PRP treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants receive three injections of cord blood platelet rich plasma (CB-PRP) or placebo into the vulvar area, each treatment spaced four weeks apart.
3 treatment visits spaced four weeks apart
Duration - 6 months after last treatment
Participants are re-evaluated at three and six months after the last treatment with vulvoscopy, biopsy, and questionnaires assessing satisfaction, symptoms, quality of life, psychological state, and sexual function.
2 follow-up visits at 3 and 6 months post-treatment
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
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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