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

RecruitingNAAges 18 Years - 49 YearsFemaleFederal State Budget Institution Research Center …
NCT07363733 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnancy or lactation; * Malignancy at the time of treatment or during any period of follow-up; * Postmenopausal status; * Severe decompensated somatic disease; * Sexually transmitted infections, including hepatitis B, hepatitis C, and syphilis; * Presence of a cardiac pacemaker or metal-containing intrauterine device (IUD); * History of treatment with other high-energy-based modalities within the last 6 months; * Use of topical corticosteroids within the last 3 months; * Immunosuppression, including immunodeficiency disorders (such as HIV/AIDS) or use of immunosuppressive medications; * Psychiatric disorders or communication difficulties that may interfere with study participation or compliance.
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What it tests

  • Dynamic Quadripolar Radiofrequency (DQRF)
  • Topical high-potency corticosteroid
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Where

1 site
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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