A Pilot Study to Evaluate the Expanded Reach of Decentralized Digital Skin Health Clinical Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,027
- 试验地点
- 2
- 主要终点
- Interaction efficiency (contacted vs. enrolled)
研究概览
简要总结
This is a randomized, decentralized, non-interventional clinical study. The primary objective of this study is to develop execution and efficiency metrics from completion of this study to inform on the potential design for future projects. The secondary objective of this study is to assess the main study endpoints across balanced attributes of study sub-populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-reported Monk skin type 1 to 10, targeting to complete at least 100 subjects for each Monk skin type.
- •18 to 65 years old, targeting to complete:
- •18- to 40-year-old age range: at least 50 subjects within each Monk type
- •41- to 65-year-old age range: at least 50 subjects within each Monk type
- •Lives within an Inner City, Urban, Suburban, or Rural community type (as determined by self-report or provided zip code), targeting to complete:
- •Inner City/Urban community type: at least 25 subjects within each age range and Monk type
- •Suburban/Rural community type: at least 25 subjects within each age range and Monk type
- •Has electronically accepted the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- •Has a personal smartphone with a camera and an internet connection (wi-fi, cellular services, etc.).
- •Intends to complete the study and willing and able to follow all study instructions.
排除标准
- •Has known allergies or adverse reactions to topical adhesives.
- •Is simultaneously participating in any other clinical study for the duration of this study or has participated in any product-use study within 30 days prior to remote Visit
- •Is an employee/contractor or immediate family member of the PI, study technology provider, laboratory, or Sponsor.
研究组 & 干预措施
Non-Skin Microbiome Subset
18- to 65-year-old female subjects.
干预措施: Lifestyle Questionnaire (Other)
Non-Skin Microbiome Subset
18- to 65-year-old female subjects.
干预措施: Self-portrait image (Face and Hair) (Other)
Skin Microbiome Subset
18- to 65-year-old female subjects randomly assigned in the skin microbiome subset
干预措施: Lifestyle Questionnaire (Other)
Skin Microbiome Subset
18- to 65-year-old female subjects randomly assigned in the skin microbiome subset
干预措施: Self-portrait image (Face and Hair) (Other)
Skin Microbiome Subset
18- to 65-year-old female subjects randomly assigned in the skin microbiome subset
干预措施: Skin microbiome collection (Diagnostic Test)
结局指标
主要结局
Interaction efficiency (contacted vs. enrolled)
时间窗: 4 weeks post Last Subject's remote visit
The number and percentage of subjects who interacted with the digital study activities vs number and percentage of subjects who completed the study.
Percent completion of subject self-taken images
时间窗: 4 weeks post Last Subject's remote visit
The number and percentage of subjects who successfully completed the self-taken images.
Percent completion of subjects participating in bio-sampling subset
时间窗: 4 weeks post Last Subject's remote visit
The number and percentage of subjects who successfully completed the bio-sampling procedures.
次要结局
- Questionnaire results compared across age groups(4 weeks post Last Subject's remote visit)
- Questionnaire results compared across skin tone(4 weeks post Last Subject's remote visit)