VALOR: Vaginal Atrophy & Long-term Observation of Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 14
- 主要终点
- Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.
研究概览
简要总结
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus
- •Continuous vulvovaginal symptoms
- •Access to smartphone and tablet, laptop or computer
- •Access to a valid email address
排除标准
- •Unable to provide informed consent
- •Patient unable to apply topical device
- •Allergy or intolerance to ingredients or excipients of the formulation of studied products
- •Systemic hormonal therapy started less than 30 days before baseline
- •Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline
- •Ongoing topical HRT or corticosteroid treatment for the indication under investigation
- •Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline
研究组 & 干预措施
Feasibility
干预措施: 7-0940 (Device)
结局指标
主要结局
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.
时间窗: 12 months
The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvovaginal Symptoms Questionnaire (VSQ) \[min:0; max:16 (for sexually inactive patients) / max: 20 (for sexually active patients)\]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VSQ score at 12 months.
Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months
时间窗: 12 months
The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvar Disease Quality of Life Index (VQLI). \[min:0; max:45\]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VQLI score at 12 months.
次要结局
- Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale(12 months)
- Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.(12 months)
- Treatment adherence(12 months)
- Change in patient-rated symptom severity assessed using a 10-point Likert scale.(12 months)
- Adverse Reactions(12 months)
- Product rating(12 months)