Skin Aging, Hair Care, Skin Microbiome
Conditions
Brief summary
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.
Interventions
All subjects will complete the lifestyle questionnaire
OTHERSelf-portrait image (Face and Hair)
All subjects will take one self-portrait image of their face and hair
DIAGNOSTIC_TESTSkin microbiome collection
Subjects randomly assigned in the skin microbiome subset will complete the skin microbiome collection
Sponsors
Kenvue Brands LLC
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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: * 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.
Exclusion criteria
* 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 1. * Is an employee/contractor or immediate family member of the PI, study technology provider, laboratory, or Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interaction efficiency (contacted vs. enrolled) | 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 | 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 | 4 weeks post Last Subject's remote visit | The number and percentage of subjects who successfully completed the bio-sampling procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire results compared across skin tone | 4 weeks post Last Subject's remote visit | The lifestyle questionnaire results will be summarized by either descriptive analysis or frequency by Monk Skin tone 1 to 10. |
| Questionnaire results compared across age groups | 4 weeks post Last Subject's remote visit | 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. |
Countries
United States
Outcome results
None listed