RecruitingNot ApplicableNCT07363733

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

Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus


Sponsor

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

Enrollment

68 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Dynamic Quadripolar Radiofrequency (DQRF) and a drug called Topical high-potency corticosteroid for people with vulvar lichen sclerosus. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 49 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDynamic Quadripolar Radiofrequency (DQRF)

Dynamic quadripolar radiofrequency therapy administered according to a standardized treatment protocol consisting of four sessions performed at two-week intervals.

DRUGTopical 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

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NCT07363733


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