Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test
研究概览
简要总结
The purpose of this study is to check the safety under normal conditions of use through the emergence of signs of irritability and sensitization of the genital mucosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 25 to 55 years old
- •Regular Menstrual Cycle
- •Intact skin in product analysis área
- •No prior reactions to topical products
- •Being a user of products from the same category
- •Reading, understanding, agreement and signature of the informed consent form
排除标准
- •Pregnancy or risk of pregnancy
- •Lactation
- •Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
- •Diseases that cause imune suppression;
- •Endocrine disorders such as thyroid, ovarian or adrenal gland disorders;
- •Any infection in the region where the product will be analyzed diagnosed at enrollment;
- •Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.
结局指标
主要结局
Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test
时间窗: 40 days
For the safety assessment, the variables will be evaluated for each experimental period using one-tailed Wilcoxon test to investigate the following hypotheses: H0: The median of the results of the variable under study is zero (no irritation) H1: The median of the results of the variable under study is greater than zero (no irritation) The Wilcoxon test is used because it is the ideal to compare variables collected with ordinal scale with a reference value. In this study, the reference value is zero (no irritation). The expectation is the absence of positive safety, ie higher scores than zero. If there are positive evidence of (mild, moderate or severe) for parameters erythema, peeling,blistering and swelling, the results are statistically evaluated.
次要结局
未报告次要终点