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

January 14, 2026 updated by: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in clinical severity of vulvar lichen sclerosus
Time Frame: Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Patient-Reported Outcomes
Time Frame: Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.
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
Time Frame: Before treatment (baseline) and at 3 months after completion of therapy.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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