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

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Status: Enrolling

Conditions: Vulvar Lichen Sclerosus

Treatments: Drug: Topical high-potency corticosteroid; Device: Dynamic Quadripolar Radiofrequency (DQRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT07363733

DQRF10.2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids

Experimental group

Description:

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.

Treatment:

Device: Dynamic Quadripolar Radiofrequency (DQRF)

Drug: Topical high-potency corticosteroid

Topical Corticosteroid Monotherapy

Active Comparator group

Description:

Participants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen.

Treatment:

Drug: Topical high-potency corticosteroid