Prospective, Randomized, Active-controlled Investigator Initiated Clinical Trial to Demonstrate That the Nd:YAG/Er:YAG Dual Laser Therapy is Effective to Treat Vulvar Lichen Sclerosus and Similar to Standard Treatment With Steroid Cream
概览
- 阶段
- 不适用
- 干预措施
- FotonaSmooth SP® Spectro laser device
- 疾病 / 适应症
- Chronic Skin Disease
- 发起方
- Prof. Dr. Volker Viereck
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Clinical Lichen sclerosus score (LS score)
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The aim of this study is to test a new, minimally invasive dual laser technique to treat vulvar lichen sclerosus. Efficacy and safety of the thermal non-ablative Nd:YAG laser and the ablative Er:YAG laser is determined and compared to the current standard treatment with high dose steroids. The hypothesis is that laser therapy is effective and similar to standard steroid therapy.
详细描述
Lichen sclerosus (LS) is a chronic inflammatory skin disease that usually involves the anogenital area where it causes itching and burning pain, pain during sexual intercourse, and anal or genital bleeding due to fissuring of the damaged tissue. In this study a treatment with dual laser application combining thermal non-ablative Nd:YAG with ablative Er:YAG laser is used to reduce the symptoms of LS. Results will be compared to the standard therapy with topical steroid cream.
研究者
Prof. Dr. Volker Viereck
Head of Urogynecology
Cantonal Hospital, Frauenfeld
入排标准
入选标准
- •Diagnosis of vulvar lichen sclerosus
- •Clinical LS score ≥ 4
排除标准
- •Concomitant steroid, calcineurin inhibitor or any other topical or systemic treatment for LS
- •\< 3 months since start of vaginal estrogen treatment
- •Malignant disease as the cause of the vulval symptoms
- •BMI \> 35 kg/m²
- •Acute infection (fungal, bacterial, viral) of the vulva, vagina or bladder
- •Presence of contraindications for the laser treatment or topical steroid treatment
研究组 & 干预措施
Laser
dual Fotona laser treatment (Nd:YAG and Er:YAG)
干预措施: FotonaSmooth SP® Spectro laser device
Topical steroid
clobetasol propionate 0.05% cream
干预措施: Clobetasol propionate 0.05% ointment
结局指标
主要结局
Clinical Lichen sclerosus score (LS score)
时间窗: 6 months
Reduction (i.e. improvement) of physician administered clinical LS score (Sum score of 6 items on a scale from 0-2 (0=no, 1=weak, 2=pronounced): erosions, hyperkeratosis, fissures, agglutination, stenosis, atrophy). Possible sum score ranges from 0 (normal) to 12 (maximum symptoms present).
次要结局
- Vulvovaginal symptom questionnaire (VSQ)(At each visit through study completion, an average of 1 year)
- Symptom strength score(At each visit through study completion, an average of 1 year)