NCT05013645已完成不适用
Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Corneometer Measurements
研究概览
简要总结
Double-blind placebo-controlled clinical trial to evaluate the effectiveness of a sterilized probiotic on skin health and hydration in adults with dry skin.
The goal of the study is to determine if the addition of a skin-conditioning probiotic to a standard gel product will moisturize the skin, support a healthy skin microbiome, and be readily tolerated by adults with dry skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of a signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability to attend study visits for the duration of the study
- •English-speaking
- •18-90 years of age
- •Score of a 2 or higher in one of the four areas assessed on the Dry Skin Area and Severity Index (DASI)
排除标准
- •Current self-reported pregnancy or active intent to conceive
- •Current lactation
- •Fever within 7 days of study enrollment
- •Self-reported use of systemic antibiotics (oral or injectable) in the past 6 weeks.
- •Any clinically significant medical or psychological disorder, condition, or disease that in the opinion of the investigator exposes the subject to unacceptable risk by participating in the study or interferes with the subject's ability to complete the study.
结局指标
主要结局
Corneometer Measurements
时间窗: Study Days 1, 14, 28, 35
Measures change in skin surface hydration at study days 1, 14, 28 and 35
Tewameter Measurements
时间窗: Study Days 1, 14, 28, 35
Measures change in rate of skin surface water loss at study days 1, 14, 28, 35
次要结局
- Skin microbiome analysis(Study Days 1, 28)
- Change in Dry Skin Area and Severity Index (DASI) between study days 1 and 28(Study Days 1, 28)
- Change in Itchiness Self Assessment (I-VAS) over study days 1, 14, 28 and 35(Study Days 1, 14, 28, 35)
- Change in Dryness Self Assessment (D-VAS) over study days 1, 14, 28 and 35(Study Days 1, 14, 28, 35)
- Change in Skindex16 Quality of Life over study days 1, 14, 28, 35(Study Days 1, 14, 28, 35)
研究者
Sharon Liebrich
Institutional Representative
Florida State University
研究点 (2)
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