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.
women with VLS (clinical/histological diagnosis)
good health conditions
written informed consent signed and dated by the patient
pregnancy
coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases
ongoing major infections
previous vulvar surgery (e.g., lipostructure and/or previous PRP)
Parallel
Infiltrative treatment with CB-PRP
Biological/VaccineInjection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP/ placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function.
Patient satisfaction in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of patient satisfaction through the compilation of the Likert scale: 0 better outcome, 10 worst outcome.
Patient Global Impression of Change in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of impression of global changes using the Patient Global Impression of Change Questionnaire. Patient Global Impression of Change is a single item questionnaire measuring the global changes since the start of the study treatment on a 7-point scale (1 better outcome, 7 worst outcome).
Change in symptomatology in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of symptoms (itching, burning, dyspareunia and dysuria) using specific likert scale: 0 no symptoms (better outcome), 10 worst symptoms (worst outcome).
Mucosal trophism in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of objective change of mucosal trophism through vulvoscopy.
Histological biopsy in treatment group vs placebo group
We expect that women in the cord blood platelets rich plasma group will differ with regard of changing of histological byopsy features, trough biopsy.
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