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

NCT06661382 | Recruiting Phase 1 DMC

• 1 other identifier: FLIPP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient Global Impression of Change in treatment group vs placebo group

  3 months

• Change in symptomatology in treatment group vs placebo group

  3 months

• Mucosal trophism in treatment group vs placebo group

  3 months

• Histological biopsy in treatment group vs placebo group

  3 months

• Sexual activity changes in treatment group vs placebo group

  3 months

Study Arms (2)

Infiltrative treatment with CB-PRP Group

EXPERIMENTAL

Biological: Infiltrative treatment with CB-PRP

Placebo infiltrative treatment Group

PLACEBO COMPARATOR

Biological: Infiltrative treatment with CB-PRP

Interventions

Infiltrative treatment with CB-PRP BIOLOGICAL

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.

Infiltrative treatment with CB-PRP Group; Placebo infiltrative treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with VLS (clinical/histological diagnosis)
• good health conditions
• written informed consent signed and dated by the patient

You may not qualify if:

• pregnancy
• coagulopathies, platelet disorders, cardiovascular and/or respiratory diseases
• ongoing major infections
• previous vulvar surgery (e.g., lipostructure and/or previous PRP)

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• veronica Boero, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Boero, MD

CONTACT

0255032318; veronica.boero@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: October 28, 2024
• Study Start: January 24, 2023
• Primary Completion: November 24, 2024
• Study Completion: December 24, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

IT (1)