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

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.

• 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 corticosteroid (Drug): Topical high-potency corticosteroid therapy administered according to the same standardized treatment regimen as in the control arm.

Primary outcomes

• Change in clinical severity of vulvar lichen sclerosus [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).

Secondary outcomes

• Changes in Patient-Reported Outcomes [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).
• Tissue-Level Biomarkers [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.

Sex: Female, ages: 18 Years to 49 Years

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.

• 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