Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Perceived hydration
研究概览
简要总结
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.
详细描述
At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Health volunteers
- •Non-injured mucosa in the test region;
- •Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations;
- •Ability to consent to their participation in the study;
- •Age from 18 to 70 years old;
- •Female participants;
- •Vaginal dryness (slight minimum) - according to questions from the gynecologist.
排除标准
- •Pregnancy or breastfeeding;
- •Skin pathology in the area of application of the product;
- •Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma;
- •Current use of the following medications for topical or systemic use:
- •corticosteroids, immunosuppressants and antihistamines;
- •Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
- •History of reaction to the category of the tested product;
- •Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.
结局指标
主要结局
Perceived hydration
时间窗: 9 days
Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"
次要结局
未报告次要终点