Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Lichen Score
研究概览
简要总结
With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.
详细描述
Vulvar Lichen sclerosus (VLS) is a chronic inflammatory cutaneous disorder, which can lead to scarring, impaired sexual function and malignancy. Gold standard treatment is topical corticosteroids (TCS) initially daily for 12 weeks. To avoid new flourishing of the disease a life-long maintenance treatment 2x/week is later recommended. Fractional CO2-Laser has shown a positive effect on vulvovaginal skin quality with improvement of urogenital atrophy and also lichen sclerosus. This randomised trial compares efficacy of laser treatment to TCS maintenance as well as the duration of the laser effect.
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)
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
- •Pre- or postmenopausal
- •12 weeks of continuous topical clobetasol treatment completed.
- •Written informed consent
- •German speaking (Study information and IC available only in German)
排除标准
- •Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use
- •Contraindication for the use of topic clobetasol
- •History of vulva laser
- •Immune-suppression
- •Pregnancy or planned pregnancy, breast feeding.
- •Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer.
- •History of vulvar or pelvic radiation therapy
- •Uncertain vulvar findings, which require a biopsy.
- •Acute vulvitis, especially recurrent genital herpes
- •History of vaginal mesh implantation within 6 months preceding this study
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- •Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
- •Previous enrolment into the current investigation
- •Enrolment of the PI, his/her family members, employees and other dependent persons
研究组 & 干预措施
Laser group
3 monthly fractional laser treatment according to the user manual (correct applicator, vulvar and vaginal preset). In between daily local skin care with a drug free product of patients' choice.
干预措施: Treatment with Monalisa Glide Laser (Device)
Clobetasol group
Maintenance treatment with vulvar TCS (clobetasol) application 2x/week. Instruction given at trial start and monthly check up for treatment control Daily local skin care with a drug free product of patients' choice.
干预措施: Treatment with Clobetasol (Drug)
结局指标
主要结局
Lichen Score
时间窗: 3 months
The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT
次要结局
- Vulva assessment Scale(15 months)
- Lichen Score Follow up(15 months)
- German Pelvic floor questionnaire(15 months)