Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With 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 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.

Study Overview

• Status: Recruiting
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Device: Dynamic Quadripolar Radiofrequency (DQRF); Drug: Topical high-potency corticosteroid

Detailed Description

This is a prospective, randomized study conducted in women reproductive age with vulvar lichen sclerosus. Computer-generated randomization using an electronic spreadsheet will be used by investigators to assign participants to study groups.

Study groups Group 1: 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. DQRF therapy will be administered using a small vulvar applicator in a total of four sessions, performed at two-week intervals.

Group 2: topical high-potency corticosteroid therapy according to a standardized regimen.

Study assessments Clinical assessment At baseline and each follow-up visit, participants will undergo standardized vulvar examination with documentation of objective signs (skin color changes, sclerosis, fissures, erosions, scarring and architectural changes) and symptom severity. Clinical severity will be assessed using a structured clinician-rated vulvar lichen sclerosus severity score. Standardized photo documentation will be performed.

Patient-reported outcome measures

Patient-reported outcomes will be assessed using validated questionnaires:

• Numeric Rating Scale (NRS) for pruritus, vulvar pain, burning, dryness and dyspareunia;
• Vulvar Quality of Life Index (VQLI);
• Short Form-12 Health Survey (SF-12);
• Female Sexual Function Index (FSFI). Histological and tissue-level assessment

Histochemical and immunohistochemical analyses will be performed in a subset of 10 patients per group. Vulvar punch biopsy specimens will be obtained before initiation of therapy and after completion of treatment for:

• immunohistochemical analysis of estrogen receptors, androgen receptors and superoxide dismutase 2 (SOD2) expression;
• histochemical assessment of elastin fiber staining intensity and distribution using a standardized elastin stain, with semi-quantitative grading and/or digital image analysis.

Safety assessment Adverse events related to topical therapy, radiofrequency treatment will be recorded throughout the study.

Follow-up period Participants will be followed longitudinally before the treatment, at the end of treatment, and at 3, 6, and 12 months after completion of therapy to evaluate short-term response, durability of clinical improvement, and disease recurrence.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khava Balashova, MD, Obstetrics and Gynecology; Phone Number: +79251864388; Email: Hava199@mail.ru

Study Locations

• Russia
  • Moscow, Russia
    • Recruiting
    • National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
    • Contact: Khava Balashova, MD, Obstetrics and Gynecology; Phone Number: +79251864388; Email: Hava199@mail.ru
    • Principal Investigator: Khava Balashova, MD, Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids; 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); Dynamic quadripolar radiofrequency therapy administered according to a standardized treatment protocol consisting of four sessions performed at two-week intervals.; Drug: Topical high-potency corticosteroid; Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.
Active Comparator: Topical Corticosteroid Monotherapy; Participants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen.	Drug: Topical high-potency corticosteroid; Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Patient-Reported Outcomes	Change from baseline in general health-related quality of life assessed using the Short Form-12 Health Survey (SF-12). Change from baseline in sexual function assessed using the Female Sexual Function Index (FSFI).	Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.
Tissue-Level Biomarkers	Change from baseline in estrogen and androgen receptor expression (percentage) in vulvar tissue assessed by immunohistochemistry in a subset of 10 patients per group. Change from baseline in superoxide dismutase (SOD) expression (percentage) in vulvar tissue assessed by immunohistochemistry in a subset of 10 patients per group. Change from baseline in elastin fiber staining intensity (percentage) and distribution in vulvar tissue assessed by histochemical analysis in a subset of 10 patients per group.	Before treatment (baseline) and at 3 months after completion of therapy.

Collaborators and Investigators

• Sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
• Investigators: 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 record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Immunohistochemistry; Glucocorticoids; vulvar lichen sclerosus; Female Sexual Function; Dynamic Quadripolar RadioFrequency
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vulvar Diseases; Vulvar Lichen Sclerosus
• Other Study ID Numbers: DQRF10.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patients data is available upon request from the authors with no identifiable information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No