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

Official title

Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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.]

Secondary outcome measures (2)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Russia · 1 center

• National Medical Research Center for Obstetrics, Gynecology and Perinatology named after A — Moscow

Identifiers

NCT: NCT07363733 · DQRF10.2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗