Laser Therapy in Women With Lichenoid Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- subjective bother of lichenoid disorders (LD)
研究概览
简要总结
Primary aim of the trial is to compare improvement of lichen symptoms according to a composite VAS scale (burning, itching and pain) between women with vulvovaginal laser therapy vs. sham laser therapy at three months.
详细描述
Background: Lichenoid Disorders (LD) include VLS (Vulvar lichen sclerosus) and LP (Lichen planus). VLS and LP are chronic skin diseases that usually affect the anogenital region. Both can cause vulvar itching, burning and pain and can lead to urinary and sexual dysfunction. Current treatment options are unsatisfactory. Vulvovaginal laser therapy might be an effective treatment option.
Study aim: To study the effectiveness of non-ablative vulvovaginal laser therapy for women with lichenoid disorders.
Design: Randomized double-blinded placebo- controlled clinical study
Study Population: Women diagnosed with LD will be recruited from a specialized University outpatient clinic.
Study groups: Participants will be randomized (1:1). Intervention group: Laser therapy (2 treatments), plus ongoing therapy Control group: Sham laser therapy (2 treatments) plus ongoing 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
- Double (Participant, Investigator)
盲法说明
The person who performs the laser treatment is unaware of the treatment given The laser devices can be used as a placebo laser by blocking the laser beam with a plug
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women age >18 years
- •diagnosed with LD (VLS or LP histologically proven)
- •Clinical LS score ≥ 4 based on the score of Günthert et al. [1]
- •Normal Pap-smear within 24 months
- •negative clinical and microscopic evaluation of vaginal fluid
- •Negative test for STD (sexually transmitted diseases) pathogens (chlamydia, gonorrhea, genital mycoplasma and trichomonas) if symptomic including abdominal pain or abnormal vaginal fluid
- •Good German language skills
- •written informed consent
- •preceding local corticoid therapy of at least 12 weeks according to the current guideline for LD
排除标准
- •women with contraindications for the use of laser on the skin
- •pregnancy
- •presence of vulvar pathology (other than lichen)
- •any vulvar/ vaginal infection
- •immunocompromised women
- •swollen lymph nodes
- •genital malignant disease
- •allergy to topical anaesthesia
- •connective tissue disease
- •keloid formation
- •Patients with a legal guardian
- •Body Mass Index > 35 kg/m²
- •History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)
- •Coagulopathy
- •patients using anticoagulants
- •patients with renal, hepatic or pulmonary-cardiovascular failure
- •patients who have undergone any kind of organ transplantation in the last three years.
结局指标
主要结局
subjective bother of lichenoid disorders (LD)
时间窗: 3 months
A visual analogue scale (VAS) is used for assessment for the subjective bother of LD symptoms. Patients are asked to indicate the degree of each of the three following LD symptoms on a scale ranging from 0 (no symptoms) to 10 (worst possible symptoms): genital symptoms of itching, burning and vaginal pain resulting in a composite VAS score
次要结局
- Patient Global Impression of Severity- PGI-S(3 months)
- Histological analysis of LD(3 months)
- subjective symptoms of lichenoid disorders(3 months)
- Patient Global Impression of Improvement- PGI-I(3 months)
- Treatment discomfort / pain(3 months)
- architectural changes(3 months)
- Patient satisfaction with treatment/ inpatient management(3 months)