Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma.

• Status: Completed
• Trial end date: 2019-12-12
• Target enrollment: 0
• Participant gender: Female

Summary

LIQUENIA clinical trial is a phase II, controlled, prospective and unicentric study to assess vulvar lichen sclerosus (VLS) treatment using adipose tissue associated with autologous platelet-rich plasma (PRP) coming from the inner side of the patients' thighs, which aims to restore the structure and elasticity of the affected vulvar subunits, and to improve vulvar subunits lesions and symptoms, therefore, patients' quality of life from the early phases of the treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe
• Treatments: Clobetasol

Criteria

Inclusion Criteria:

• Adult women between 18 and 70 years old.

• Patients with clear clinical and/or histological diagnosis of vulvar lichen sclerosus (VLS).

• Moderate to severe affectation of the disease at genital level.

• Patients who have taken topical treatment for at least three months with 0.05% clobetasol propionate.

• Prior signed informed consent form.

Exclusion Criteria:

• Pregnant or lactating women.

• Alcoholic patients.

• Patients with malignant disease diagnosed in the last 5 years.

• Patients infected with HSV-II, HPV, HIV, HBV and HCV viruses.

• Injecting drug users.

• Patients with serious active infectious diseases.

• Patients with known allergy or intolerance to any of the aforementioned treatments.

• Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, psoriasis, eczema).

• Patients with unrealistic expectations regarding the final benefits of the treatment.