NCT03007615Unknown不适用
Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.
Kley Hertz S/A0 个研究点目标入组 33 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 33
- 主要终点
- Evaluation of the product's efficiency as a moisturizer through subjective evaluation
研究概览
简要总结
To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female sex with active sex life;
- •Age group: between 45 and 65 years old;
- •Menopause for at least six months;
- •Whole skin in the region of product analysis;
- •No history of reaction to products of the same category
- •Understanding, agreement and signature of the Term of Free and Informed Consent.
排除标准
- •Gestation or risk of gestation;
- •Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
- •Active cutaneous pathologies (local and / or disseminated) in the evaluation area;
- •Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;
- •Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;
- •Any infection in the region of analysis of the product diagnosed at the time of inclusion;
- •Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.
结局指标
主要结局
Evaluation of the product's efficiency as a moisturizer through subjective evaluation
时间窗: 30 days
次要结局
未报告次要终点
研究者
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