A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Skindex-29 Score
研究概览
简要总结
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
详细描述
Vulvar lichen sclerosus is a common benign skin condition which causes pain and itching. Topical steroids have been the main treatment. A recent study showed that fractionated CO2 laser treatment is non inferior and actually may improve subjective symptoms compared to topical steroids with no serious safety or adverse events. Because steroids reduce risk of vulvar cancer in patients with lichen sclerosus, the investigators hypothesize that steroids in addition to the fractionated laser will provide greater symptom relief while still allowing patient the benefits of steroid treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores >21
排除标准
- •prior vaginal mesh or pelvic radiation
- •active genital infection
- •Current or past gynecologic malignancy
研究组 & 干预措施
Fractionated CO2 laser plus topical steroids
3 laser treatments at 6 week intervals for 6 months by a single trained operator
干预措施: MonaLisa Touch (Device)
Fractionated CO2 laser plus topical steroids
3 laser treatments at 6 week intervals for 6 months by a single trained operator
干预措施: Topical steroid (Drug)
topical steroids alone
self-applied topical steroid therapy using clobetasol propionate 0.05%
干预措施: Topical steroid (Drug)
结局指标
主要结局
Change in Skindex-29 Score
时间窗: Completed by the subject at baseline and 6 months.
The Skindex-29 is a validated tool to assess impact of a chronic skin condition on a person's quality of life. It has been previously used to describe the effects of a treatment and to compare treatments. Values range from 1 (Never) to 5 (All the time). The higher the score, the worse the outcome.
次要结局
- Change in Objective Visual Analog Scale(Scored by the provider at baseline and 6 months)
- Change in Vulvovaginal Symptoms Questionnaire (VSQ) Score (Total Score)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Symptoms Component Only)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Emotion Component Only)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Life Impact Component Only)(Administered at baseline and at 6 months by the provider.)
- Change in Vulvovaginal Symptoms Questionnaire Score (Sexual Impact Component Only)(Administered at baseline and 6 months by an investigator to the subject)
- Change in Symptom Subjective Visual Analog Score(Administered at baseline and 6 months by an investigator to the subject)