Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Reduction of genital odor and increase hydration in genital mucosa
研究概览
简要总结
Primary Objective:
- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional
Secondary Objective:
- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dermacyd (different fragrances)
Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional
干预措施: LACTIC ACID (Dermacid) (Drug)
Dermacyd (different fragrances)
Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional
干预措施: Glycerine Vegetal Soap Granado Traditional (Drug)
Glycerine Vegetal Soap Granado Traditional
Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)
干预措施: LACTIC ACID (Dermacid) (Drug)
Glycerine Vegetal Soap Granado Traditional
Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)
干预措施: Glycerine Vegetal Soap Granado Traditional (Drug)
结局指标
主要结局
Reduction of genital odor and increase hydration in genital mucosa
时间窗: From the treatment start to the end of the study (day 67)
Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale.
次要结局
- Evaluation of the integrity of the mucosa(From the treatment start to the end of the study (day 67))