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Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Summary
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.
Official title: Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus
Key Details
Gender
FEMALE
Age Range
18 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2026-01
Completion Date
2027-02
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Dynamic Quadripolar Radiofrequency (DQRF)
Dynamic quadripolar radiofrequency therapy administered according to a standardized treatment protocol consisting of four sessions performed at two-week intervals.
Topical high-potency corticosteroid
Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.
Locations (1)
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
Moscow, Russia