Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Recruiting now · Not applicable
Conditions studied: Vulvar Lichen Sclerosus
In brief
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.
Key facts
- Study ID
- NCT07363733
- Run by
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- People needed
- 68
- Starts
- 2026-01-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation — Moscow, Russia (enrolling)
Full record on ClinicalTrials.gov
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