Vulvar Lichen SclerosusNCT07363733
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
A study testing Dynamic Quadripolar Radiofrequency (DQRF) and Topical high-potency corticosteroid in people with Vulvar Lichen Sclerosus, run by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Dynamic Quadripolar Radiofrequency (DQRF) and Topical high-potency corticosteroid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
Moscow
Khava Balashova, MD, Obstetrics and Gynecology, +79251864388, Hava199@mail.ru
Khava Balashova, MD, Obstetrics and Gynecology
About this study
Official title: 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.
Read the 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.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Dynamic Quadripolar Radiofrequency (DQRF), Topical high-potency corticosteroid
- Keywords
- vulvar lichen sclerosus, Dynamic Quadripolar RadioFrequency, Glucocorticoids, Immunohistochemistry, Quality of Life, Female Sexual Function
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Topical high-potency corticosteroidDrug
Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Topical high-potency corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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.
Measured: Before treatment (baseline) and at 3 months after completion of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Khava Balashova, MD, Obstetrics and Gynecology, Principal investigator, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363733
- Sponsor's protocol ID
- DQRF10.2025
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients data is available upon request from the authors with no identifiable information
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT07363733
- Acronym / sponsor ID
- DQRF10.2025
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- vulvar lichen sclerosus, Dynamic Quadripolar RadioFrequency, Glucocorticoids, Immunohistochemistry, Quality of Life, Female Sexual Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of HealthcareOther government
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids | Experimental | Device: Dynamic Quadripolar Radiofrequency (DQRF), Drug: Topical high-potency corticosteroidParticipants 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. |
| Topical Corticosteroid Monotherapy | Active comparator | Drug: Topical high-potency corticosteroidParticipants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Quadripolar Radiofrequency (DQRF)Dynamic quadripolar radiofrequency therapy administered according to a standardized treatment protocol consisting of four sessions performed at two-week intervals. | Device | Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids |
| Topical high-potency corticosteroidTopical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm. | Drug | Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids, Topical Corticosteroid Monotherapy |
Primary outcome
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).
2 secondary outcomes
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.
Tissue-Level Biomarkers
Time frame: Before treatment (baseline) and at 3 months after completion of therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. Patients data is available upon request from the authors with no identifiable information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khava Balashova, MD, Obstetrics and Gynecology principal investigator
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov, Ministry of Health of the Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Quadripolar Radiofrequency (DQRF) and Topical high-potency corticosteroid in people with Vulvar Lichen Sclerosus, run by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khava Balashova, MD, Obstetrics and Gynecology (+79251864388, Hava199@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.