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

NCT07363733 | Recruiting

• 1 other identifier: DQRF10.2025
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Lichen Sclerosus

Keywords

vulvar lichen sclerosus; Dynamic Quadripolar RadioFrequency; Glucocorticoids; Immunohistochemistry; Quality of Life; Female Sexual Function

Outcome Measures

Primary Outcomes (1)

• Change in clinical severity of vulvar lichen sclerosus

  Change from baseline in patient-reported symptom intensity using validated questionnaire (Numeric Rating Scale (NRS) for pruritus, vulvar pain, burning, dryness and dyspareunia).

  Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.

Secondary Outcomes (2)

• Changes in Patient-Reported Outcomes

  Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.

• Tissue-Level Biomarkers

  Before treatment (baseline) and at 3 months after completion of therapy.

Study Arms (2)

Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids

EXPERIMENTAL

Participants receive topical high-potency corticosteroid therapy according to the standardized regimen, followed by combined Dynamic Quadripolar Radiofrequency (DQRF) therapy initiated 2 weeks after the start of corticosteroid treatment.

Device: Dynamic Quadripolar Radiofrequency (DQRF); Drug: Topical high-potency corticosteroid

Topical Corticosteroid Monotherapy

ACTIVE COMPARATOR

Participants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen.

Drug: Topical high-potency corticosteroid

Interventions

Dynamic Quadripolar Radiofrequency (DQRF) DEVICE

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

Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids

Topical high-potency corticosteroid DRUG

Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.

Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids; Topical Corticosteroid Monotherapy

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

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

Study Sites (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

RECRUITING

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khava Balashova, MD, Obstetrics and Gynecology

CONTACT

+79251864388; Hava199@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)