This is a prospective, randomized study in women of reproductive age with vulvar lichen sclerosus. Participants will be randomly assigned by investigators using a computer-generated sequence to receive either combined dynamic quadripolar radiofrequency (DQRF) plus topical corticosteroid therapy or topical high-potency corticosteroid therapy alone. Clinical outcomes, patient-reported outcomes and tissue-level changes evaluated by histology, elastin histochemistry, and immunohistochemistry for estrogen, androgen receptors and superoxide dismutase 2 (SOD2) will be assessed before and after treatment, and during follow-up at 3, 6, and 12 months. Safety will be monitored throughout the study. Histochemical and immunohistochemical analyses will be performed in a subset of 10 patients per group before the treatment and at 3 months after the completion of treatment.
Women aged 18 to 49 years (women of reproductive age);
Histologically confirmed diagnosis of vulvar lichen sclerosus;
Written informed consent to participate in the study.
Pregnancy or lactation;
Malignancy at the time of treatment or during any period of follow-up;
Postmenopausal status;
Severe decompensated somatic disease;
Parallel
Dynamic Quadripolar Radiofrequency (DQRF)
DeviceDynamic quadripolar radiofrequency therapy administered according to a standardized treatment protocol consisting of four sessions performed at two-week intervals.
Topical high-potency corticosteroid
DrugTopical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.
Change in clinical severity of vulvar lichen sclerosus
Change from baseline in patient-reported symptom intensity using validated questionnaire (Numeric Rating Scale (NRS) for pruritus, vulvar pain, burning, dryness and dyspareunia).
Changes in Patient-Reported Outcomes
Change from baseline in general health-related quality of life assessed using the Short Form-12 Health Survey (SF-12). Change from baseline in sexual function assessed using the Female Sexual Function Index (FSFI).
Tissue-Level Biomarkers
Change from baseline in estrogen and androgen receptor expression (percentage) in vulvar tissue assessed by immunohistochemistry in a subset of 10 patients per group. Change from baseline in superoxide dismutase (SOD) expression (percentage) in vulvar tissue assessed by immunohistochemistry in a subset of 10 patients per group. Change from baseline in elastin fiber staining intensity (percentage) and distribution in vulvar tissue assessed by histochemical analysis in a subset of 10 patients per group.
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