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

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Biological: Infiltrative treatment with CB-PRP

Detailed Description

Lichen Sclerosus (LS) is a cutaneous-mucosal dermatosis characterized by chronic changes in the trophism and maturation of the epithelium and the connective tissue. In females, the vulvar region is affected in about 90% of cases, often constituting the only site involved. In the adult female, the predominant symptoms are vulvar itching and burning due to scratching abrasions. Dyspareunia is an often associated. The clinical course is irregular but progressive and is characterized by periods of relative quiescence alternating with episodes of exacerbation of symptoms. The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of LS 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 to achieve adequate compensation of the pathology, and significant changes may set in of the vulvar anatomy resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such a regenerative medicine. The term PRP (Platelet Rich Plasma) is used to describe a blood product blood 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. In addition to platelets, PRP contains large amounts of chemical mediators that promote angiogenesis, recruitment and proliferation of cells implicated in tissue regeneration and healing. PRP can be produced from autologous, homologous (donor) blood or from cord blood (CB-PRP). The main difference between PRP from peripheral blood (PB-PRP) and that from cord blood concerns the relative amount of growth factors and pro- and anti-inflammatory molecules. CB-PRP has been shown to be advantageous from a therapeutic point of view compared with PB-PRP because it contains higher concentrations of anti-inflammatory molecules. In addition, the use of CB-PRP allows for a final product that is not conditioned by the patient's age and by any associated comorbidities, which may instead compromise the quality of PB-PRP. Finally, the advantages of CB-PRP are related to lower production costs and to the greater ease of product preparation. The preparation process of CB-PRP involves a collection of cord blood following the expulsion of the placenta. The blood is then centrifugated using a two-step process. The final product is then injected on the vulvar surface under vulvoscopic guidance. Treatment with PRP is free of any major side effects. The objective of the following study is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Veronica Boero, MD; Phone Number: 0255032318; Email: veronica.boero@policlinico.mi.it

Study Locations

• Italy
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    • Contact: Veronica Boero, MD; Email: veronica.boero@policlinico.mi.it
    • Contact: Giulia Cetera, MD; Email: giuliaemily.cetera@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infiltrative treatment with CB-PRP Group	Biological: Infiltrative treatment with CB-PRP; Injection 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.
Placebo Comparator: Placebo infiltrative treatment Group	Biological: Infiltrative treatment with CB-PRP; Injection 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months
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).	3 months
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.	3 months
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.	3 months
Sexual activity changes in treatment group vs placebo group	We expect that women in the cord blood platelets rich plasma group will differ with regard of change in sexual life (considering sexual activity and sexual items like desire, orgasm, pain, lubrication and arousal) using Female Sexual Function Index.	3 months
Quality of life changes in treatment group vs placebo group	We expect that women in the cord blood platelets rich plasma group will differ with regard quality of life, through Short Form Health Survey (12 items.	3 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: veronica Boero, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Estimated): November 24, 2024
• Study Completion (Estimated): December 24, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Vulvar Diseases; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: FLIPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No