A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
研究概览
简要总结
This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.
详细描述
Participants will use the Love Wellness pH Balanced Cleanser daily during showers. Questionnaires will be completed at Baseline, first use, Week 2, Week 4, Week 6, and Week 8. Vaginal pH testing will be conducted weekly using Vaginox vaginal pH testing strips. The primary objective is to assess parameters of vulvar and vaginal health, while the secondary objective is to evaluate product tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 18+
- •Self-reported issues with vaginal odor, itching, or intimate skin discomfort
- •Previous use of vaginal cleansers without severe adverse reactions
- •Generally healthy without uncontrolled chronic diseases
- •Willing to avoid intra-vaginal products during the study
- •Consistent use of any vaginal health-targeted supplements for at least 3 months prior
排除标准
- •Pre-existing chronic conditions preventing protocol adherence
- •Planned reproductive health procedures
- •Recent changes in medications or supplements targeting vaginal health
- •Known severe allergic reactions
- •Pregnancy, breastfeeding, or attempting to conceive
- •Unwillingness to follow study protocol
- •History of vaginal, cervical, vulvar, uterine, or ovarian cancer
- •Recent changes or discontinuation of hormonal birth control
- •Recent surgeries or invasive treatments
结局指标
主要结局
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
时间窗: Baseline and Week 8
Vaginal pH testing will be conducted weekly from Baseline to Week 8.
次要结局
- Tolerability of pH Balanced Cleanser(Baseline, first use, Week 2, Week 4, Week 6, Week 8)