Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy (ASSIST-VLA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Vaginal Health Index Score (VHIS)
研究概览
简要总结
Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment. Clinical outcomes will be assessed using validated investigator- and patient-reported measures, with safety and symptom progression monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 vaginal atrophy
- •Access to smartphone and tablet, laptop or computer
- •Access to a valid email address
- •Previously completed laser therapy session schedule
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 or steroidal therapy started less than 30 days before baseline ( = not yet on a stable regimen)
研究组 & 干预措施
Safety
干预措施: 7-940 (Device)
结局指标
主要结局
Vaginal Health Index Score (VHIS)
时间窗: 30 - 45 days
Objective clinical assessment for assessment of the device safety as adjunctive treatment after laser therapy forr women with vaginal atrophy. The objective validation of clinical signs (elasticity, fluid volume, pH, epithelial integrity, moisture) using a commonly used scale.
Vulvar Disease Quality of Life Index questionnaire
时间窗: 30 - 45 days
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 secondary endpoint is the change from baseline VQLI score at 30 - 45 days.
Investigator-reported improvement in vaginal atrophy signs
时间窗: 30-45 days
Signs (dryness, tissue thinning, erosion, fissures, erythema, scarring, contact bleeding, labial fusion, labia reabsorption and contracture of posterior introitus) are rated by the investigator during a physical assessment at baseline and after 30 - 45 days, using a 10-point Likert scale ranging from 0=normal to 10=worst possible.
Recovery Improvement Question
时间窗: 30-45 days
Descriptive patient-related questions, assessing the improvement post-laser therapy.
次要结局
- Change in complication rate(30 - 45 days)