Efficacy of Nd:Yttrium Aluminum Garnet Laser Treatment of Lichen Sclerosus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months
研究概览
简要总结
This study evaluates the efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.
详细描述
Lichen sclerosus (LS) is a chronic skin disease of unknown cause and very unpleasant symptoms which significantly influences the quality of life of the affected patients. Large majority of LS lesions is located in anogenital region where initial white flat papules usually develop into large, white patches of thin, itchy skin causing fusion of labia minora, narrowing of the introitus and burying of the clitoris. Most common symptoms are itching, pain, soreness, burning, dyspareunia and dysuria all strongly interfering with sexual function and patient's self image. Existing treatment options with systemic and topical medications (oral retinoids, topical steroids) have some drawbacks and recently the use of laser was proposed for treatment of LS. This study evaluates the safety and efficacy of Nd:Yttrium Aluminum Garnet Laser (Nd:YAG) Treatment of Lichen sclerosus in comparison with topical corticosteroid treatment. Half of participants will receive laser treatment and the other half corticosteroid treatment and the results will be followed for 6 months.
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 (Outcomes Assessor)
盲法说明
Hystology and photographic assessment performed by independant investigators unaware of the assignement.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed Lichen sclerosus
- •voluntary signed informed consent
排除标准
- •pregnancy
- •use of photosensitizing medication
- •pathology other than Lichen
- •damage of tissues in the treatment area
- •other inflammation
- •refusal to sign informed consent
研究组 & 干预措施
Topical Corticosteroid Diprosone
Topical corticosteroid betamethasone (Diprosone, Merck Sharp & Dohme, d.o.o.) for 3 months.
干预措施: Topical corticosteroid Diprosone (Drug)
结局指标
主要结局
Change in Visual analog scale (VAS) score symptom evaluation from baseline to 3 months
时间窗: Change from baseline to 3 months
Patients will evaluate symptoms on a 0-10 VAS scale
次要结局
- Comparative histological evaluation(baseline and 3 months)
- patient satisfaction(6 months)
- evaluation of improvement from clinical photographs(3 months)
- Change in Visual analog scale (VAS) score symptom evaluation from baseline to 1 month(Change from baseline to 1 month)
- Change in Visual analog scale (VAS) score symptom evaluation from baseline to 6 months(Change from baseline to 6 months)
研究者
Dr Adolf Lukanovič
Medical Director of the Division of Gynaecology
University Medical Centre Ljubljana