NCT07363733 Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
| NCT ID | NCT07363733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare |
| Condition | Vulvar Lichen Sclerosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2026-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2026-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Khava Balashova, MD, Obstetrics and Gynecology
PRINCIPAL INVESTIGATOR
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
Frequently Asked Questions
Who can join the NCT07363733 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Vulvar Lichen Sclerosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07363733 currently recruiting?
Yes, NCT07363733 is actively recruiting participants. Contact the research team at Hava199@mail.ru for enrollment information.
Where is the NCT07363733 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07363733 clinical trial?
NCT07363733 is sponsored by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare. The principal investigator is Khava Balashova, MD, Obstetrics and Gynecology at National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation. The trial plans to enroll 68 participants.