Radiofrequency plus steroid cream versus steroid cream alone for 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

This trial tests whether adding dynamic quadripolar radiofrequency to standard high‑potency steroid cream helps women of reproductive age with vulvar lichen sclerosus more than steroid cream alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 49 Years
• Sex: Female
• Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare (Government)
• Locations: 1 site (Moscow)
• Trial ID: NCT07363733 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized study enrolling women aged 18–49 with biopsy-confirmed vulvar lichen sclerosus who are assigned to either topical high‑potency corticosteroid alone or the same steroid regimen plus four sessions of dynamic quadripolar radiofrequency (DQRF). DQRF is delivered with a small vulvar applicator in four sessions at two‑week intervals starting two weeks after corticosteroid initiation. Outcomes include clinician-rated clinical severity scores, standardized photo documentation, multiple patient-reported outcome measures (pruritus, pain, VQLI, SF-12, FSFI), and safety monitoring with follow-up at 3, 6, and 12 months. Tissue-level changes by histology, elastin histochemistry, and immunohistochemistry (estrogen/androgen receptors, SOD2) will be measured in a subset of 10 patients per group before treatment and at 3 months after completion.

Who should consider this trial

Good fit: Women aged 18–49 with histologically confirmed vulvar lichen sclerosus who can consent, are not pregnant or breastfeeding, and have not used topical corticosteroids in the prior 3 months are appropriate candidates.

Not a fit: Postmenopausal women, pregnant or lactating patients, those with active malignancy, active sexually transmitted infections, immunosuppression, or contraindications to radiofrequency (for example a cardiac pacemaker or metal IUD) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding DQRF to topical steroids could reduce symptoms and improve vulvar tissue structure and quality of life more than steroids alone.

How similar studies have performed: Energy‑based devices have shown some benefit for vulvovaginal symptoms in other settings, but combining DQRF with topical corticosteroids for vulvar lichen sclerosus is relatively novel and not yet well established.

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.

Where this trial is running

Moscow

• National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation — Moscow, Russia (Recruiting)

Study contacts

• Principal investigator: Khava Balashova, MD, Obstetrics and Gynecology — National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
• Study coordinator: Khava Balashova, MD, Obstetrics and Gynecology

Conditions Vulvar Lichen Sclerosus; vulvar lichen sclerosus; Dynamic Quadripolar RadioFrequency; Glucocorticoids; Immunohistochemistry; Quality of Life; Female Sexual Function