NCT06389071招募中不适用
Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sciton
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Histological clearance
研究概览
简要总结
Fractional ablative laser treatment for Lichen Sclerosus lesion
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged 18 years or older
- •Biopsy-proven vulvar lichen sclerosus lesion
- •Experiencing one or more of the following symptoms of LS:
- •Easily bruises
- •Easily tears
- •Ulcerated lesions
- •Painful intercourse
- •Negative urine pregnancy test if subject is of childbearing potential before enrollment
- •Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
- •Ability to understand and sign informed consent, questionnaires, and all investigation requirements
- •Willing to consent to clinical photographs of the treatment area
- •Willing to consent to ultrasound images of the treatment area
- •Willing and able to logistically follow schedule of treatments and follow-up visits
排除标准
- •Pregnancy, less than 3 months postpartum, or planning to become pregnant during the investigation to protect integrity of the data
- •Is a nursing mother
- •History of uncontrolled malignant disease
- •Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection)
- •Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
- •Subjects with genital skin disease, psoriasis due to risk of koeberizing
- •Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin
- •Known allergy or intolerance to local anesthesia
- •Known history of connective tissue disease
- •Known propensity for keloid formations
- •Known medical condition that may affect wound healing
- •Any reason that the investigator deems prohibits participation in the investigation
研究组 & 干预措施
Treatment + PRP Arm
Active Comparator
干预措施: Fractional 2940 nm Laser (Device)
Treatment only Arm
Active Comparator
干预措施: Fractional 2940 nm Laser (Device)
结局指标
主要结局
Histological clearance
时间窗: 16 weeks
Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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