Randomized Clinical Trial of the Efficacy of Combined Dynamic Quadripolar Radiofrequency Therapy VS Topical Corticosteroid Therapy in Women With Vulvar Lichen Sclerosus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in clinical severity of vulvar lichen sclerosus
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids
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.
干预措施: Dynamic Quadripolar Radiofrequency (DQRF) (Device)
Dynamic Quadripolar Radiofrequency Plus Topical Corticosteroids
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.
干预措施: Topical high-potency corticosteroid (Drug)
Topical Corticosteroid Monotherapy
Participants receive topical high-potency corticosteroid therapy according to a standardized treatment regimen.
干预措施: Topical high-potency corticosteroid (Drug)
结局指标
主要结局
Change in clinical severity of vulvar lichen sclerosus
时间窗: 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).
次要结局
- Changes in Patient-Reported Outcomes(Before treatment (baseline), at the end of treatment, and at 3, 6, and 12 months after completion of therapy.)
- Tissue-Level Biomarkers(Before treatment (baseline) and at 3 months after completion of therapy.)