NCT02509403撤回1 期
An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants without any adverse events as a measure of safety
研究概览
简要总结
The purpose of this study is to assess the safety (absence of skin irritation) of a feminine hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. The feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.
详细描述
The design of the trial will be open-label and uncontrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Women aged ≥18 years willing to use the perineal towels for an entire month
排除标准
- •Pregnancy or within 12 months post-partum
- •Current vulvo-vaginitis
- •Known allergies to tea-tree oil
研究组 & 干预措施
Intervention
Experimental
Essential oils infused Perineal Hygiene wipe
干预措施: Essential oils infused Perineal Hygiene wipe (Drug)
结局指标
主要结局
Number of participants without any adverse events as a measure of safety
时间窗: 45 Days
Number of participants without any adverse events
次要结局
- Self-reported comfort score on a scale of 1 to 10(30 Days)
- Ease of use of the perineal hygiene wipe by the participants on a daily basis(30 Days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Acceptability Dermacyd Wipes - Lactoserum - HygieneHygieneNCT00397527Sanofi30
已完成
3 期
Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - HygieneHygieneNCT00370162Sanofi30
已完成
4 期
Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)HygieneNCT00497783Sanofi30
已完成
不适用
Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal HealthVaginal Personal CareNCT05659745Seed Health70
已完成
3 期
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower BackHealthyNCT01055262Pfizer169