NCT06661382 Use of Platelet Rich Plasma from Cord Blood Vs Placebo in the Treatment of Vulvar Lichen Sclerosus
| NCT ID | NCT06661382 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Vulvar Lichen Sclerosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-24 |
| Primary Completion | 2024-11-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2023-01-24 with a primary completion date of 2024-11-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * women with VLS (clinical/histological diagnosis) * good health conditions * written informed consent signed and dated by the patient Exclusion Criteria: * pregnancy * coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases * ongoing major infections * previous vulvar surgery (e.g., lipostructure and/or previous PRP)
Contact & Investigator
veronica Boero, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Frequently Asked Questions
Who can join the NCT06661382 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Vulvar Lichen Sclerosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06661382 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06661382 currently recruiting?
Yes, NCT06661382 is actively recruiting participants. Contact the research team at veronica.boero@policlinico.mi.it for enrollment information.
Where is the NCT06661382 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06661382 clinical trial?
NCT06661382 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The principal investigator is veronica Boero, MD at Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 100 participants.