Study Comparing Dynamic Quadripolar Radiofrequency Therapy Plus Topical Corticosteroids Versus Topical Corticosteroids Alone in Women Ages 18 to 49 With Vulvar Lichen Sclerosus

What this Trial Is About

Researchers are evaluating treatments for vulvar lichen sclerosus in women of reproductive age. This prospective, randomized study compares the effects of combined dynamic quadripolar radiofrequency DQRF therapy plus topical high-potency corticosteroids with topical corticosteroid therapy alone. The study aims to assess clinical outcomes, patient-reported symptoms, and tissue-level changes in vulvar skin using histology and immunohistochemistry. Safety will be monitored throughout the study period. Participants will be randomly assigned to one of two groups. One group will receive topical corticosteroid therapy following a standardized regimen, followed by four sessions of DQRF therapy every two weeks starting two weeks after corticosteroid initiation. The other group will receive only the topical corticosteroid treatment. Tissue biopsies will be taken from a subset of participants before treatment and three months after treatment completion to analyze estrogen and androgen receptor expression, elastin fibers, and superoxide dismutase 2 SOD2 levels. During the study, participants will have regular clinical assessments at baseline, end of treatment, and at 3, 6, and 12 months after treatment completion. These visits include vulvar examinations, documentation of skin changes and symptoms, and patient questionnaires on itching, pain, burning, dryness, sexual function, and quality of life. Safety and adverse events related to treatments will be tracked throughout. The main outcome measured is the change in clinical severity of vulvar lichen sclerosus over time, alongside patient-reported outcomes and tissue biomarker changes.

Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus