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.

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.