Single Center, Open, Cross-over, Phase III Study for Safety and Efficacy (Subjective and Instrumental) Comparative Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional for Intimate Use in Menopauses Woman.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Transepidermal water loss measurement (TEWL) and corneometry
研究概览
简要总结
Primary Objective:
To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception.
Secondary Objective:
To evaluate the safety in normal condition of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 2
Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR
干预措施: Dermacid Silver (Lactic acid) (Drug)
Group 1
Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional
干预措施: Dermacid Silver (Lactic acid) (Drug)
Group 1
Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional
干预措施: Glycerine Vegetal Soap Granado Traditional (Drug)
Group 2
Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR
干预措施: Glycerine Vegetal Soap Granado Traditional (Drug)
结局指标
主要结局
Transepidermal water loss measurement (TEWL) and corneometry
时间窗: Up to Week 9
Measures taken at all visits by Tewameter equipment TM 300. The value of the average will be considered for analysis of final results. Corneometry: Measures taken at all visits by Corneometer equipment MPA 580.
次要结局
未报告次要终点