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;
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Lead sponsor