Effect of Treatment With the Ablative Fractional Carbodioxide Laser in Vulvar Lichen Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Vulvar pain measured with the visual analog scale with a range from 0 (no pain, best Outcome) to 10(worst pain, worst Outcome)
研究概览
简要总结
Aim of this study is to evaluate the therapeutic effect of the laser treatment in vulvar LS, mainly the reduction of existing symptoms. As measured by visual analogue scale (VAS) symptoms as itching, burning, pain will be determined six weeks after the last laser treatment. Secondary endpoints will be sexual function measured with the female sexual function index (FSFI) and the vulvar skin changes measured by the Lichen score (LS).
Regular photo-documentation of the treated skin will demonstrate a potential change of the tissue.
详细描述
Lichen sclerosus (LS) is a vulvar dermatosis that changes the skin to white plaques (lichenification), less elasticity (sclerosis) and the tissue shows contractions with erosions and fissures. Gold standard for the therapy of LS is the topical application of ultrapotent corticosteroids, proper treatment reverses the underlying inflammation of LS, reduces symptoms as itching and burning and may lower the risk of getting vulvar cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system. Treatment with the fractional microablative carbodioxide Laser is a minimal invasive procedure. In the literature only few published reliable data in laser therapy of vulvar skin diseases can be found, there is only one survey especially for the treatment of vulvar LS. However, published data show a potential that justifies the use of this method for the indication in treating LS.
Aim of this study is to evaluate the therapeutic effect of the laser treatment in vulvar LS, mainly the reduction of existing symptoms. But there is little comparable data, so the necessary frequency of treatment, the dose of laser application, additional use of corticosteroid or the sustainability is not yet known
Aim of this study is to evaluate the therapeutic effect of the laser treatment in vulvar LS, mainly the reduction of existing symptoms. As measured by visual analogue scale (VAS) symptoms as itching, burning, pain will be determined six weeks after the last laser treatment. Secondary endpoints will be sexual function measured with the female sexual function index (FSFI) and the vulvar skin changes measured by the Lichen score (LS).
Regular photo-documentation of the treated skin will demonstrate a potential change of the tissue.
Primary endpoint will be the outcome after laser application, the change in symptoms between both groups. As secondary endpoint it is important to see, weather sexual functions will be influenced in this therapy.
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
- 否
入选标准
- •Women aged >18 years
- •Women with histological assured or clinical confirmed Lichen sclerosus (Lichen score > 5)
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
排除标准
- •Unable to read or understand study patient information document
- •Patients with a legal guardian
- •Refusal to participate
- •Missing signed consent
- •Pregnancy and lactation
- •Proven bacterial or parasitic infection (clinical examination and/or vaginal wet mount)
- •Vulvar cancer
结局指标
主要结局
Vulvar pain measured with the visual analog scale with a range from 0 (no pain, best Outcome) to 10(worst pain, worst Outcome)
时间窗: End 12/2020. The measurements will be taken before each treatment and at the Follow-ups at 12 weeks and 18 weeks
Primary objective of this study is the number of patients with reduction or cure of the symptoms of LS as itching, burning and vulvar pain after treatment is reduced. The effect will be measured with the visual analog scale.
次要结局
- Sexual functioning measured with the Female Sexual Function Index (FSFI), each question ranges from 0 to 5 and the full scale score will be calculated(ranges from 2 (worst Outcome) to 36 (best Outcome))(End 12/2020. The measurements will be taken before each treatment and at the Follow-ups at 12 weeks and 18 weeks)