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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Skin Microbiome Subset | 18- to 65-year-old female subjects. |
| |
| Skin Microbiome Subset | 18- to 65-year-old female subjects randomly assigned in the skin microbiome subset |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Questionnaire | Other | All subjects will complete the lifestyle questionnaire |
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| Measure | Description | Time Frame |
|---|---|---|
| Interaction efficiency (contacted vs. enrolled) | The number and percentage of subjects who interacted with the digital study activities vs number and percentage of subjects who completed the study. | 4 weeks post Last Subject's remote visit |
| Percent completion of subject self-taken images | The number and percentage of subjects who successfully completed the self-taken images. | 4 weeks post Last Subject's remote visit |
| Percent completion of subjects participating in bio-sampling subset | The number and percentage of subjects who successfully completed the bio-sampling procedures. | 4 weeks post Last Subject's remote visit |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire results compared across skin tone | The lifestyle questionnaire results will be summarized by either descriptive analysis or frequency by Monk Skin tone 1 to 10. | 4 weeks post Last Subject's remote visit |
| Questionnaire results compared across age groups |
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Inclusion Criteria:
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:
Lives within an Inner City, Urban, Suburban, or Rural community type (as determined by self-report or provided zip code), targeting to complete:
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.
Exclusion Criteria:
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The target population is 18- to 65-year-old, healthy female subjects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laina Enterprises, Inc. | Apopka | Florida | 32712 | United States |
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| Self-portrait image (Face and Hair) | Other | All subjects will take one self-portrait image of their face and hair |
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| Skin microbiome collection | Diagnostic Test | Subjects randomly assigned in the skin microbiome subset will complete the skin microbiome collection |
|
The lifestyle questionnaire results will be summarized by either descriptive analysis or frequency by age groups 18- to 40-year-old and 41- to 65-year-old. |
| 4 weeks post Last Subject's remote visit |