A Pilot Study to Evaluate the Expanded Reach of Decentralized Digital Skin Health Clinical Studies

Kenvue Brands LLC

Status: Completed

Conditions: Hair Care; Skin Microbiome; Skin Aging

Treatments: Other: Self-portrait image (Face and Hair); Diagnostic Test: Skin microbiome collection; Other: Lifestyle Questionnaire

Study type: Observational

Funder types: Industry

Identifiers

NCT07193290

CS2024SK100177

Details and patient eligibility

About

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.

Enrollment: 1,027 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,027 participants in 2 patient groups

Non-Skin Microbiome Subset

Description:

18- to 65-year-old female subjects.

Treatment:

Other: Lifestyle Questionnaire

Other: Self-portrait image (Face and Hair)

Skin Microbiome Subset

Description:

18- to 65-year-old female subjects randomly assigned in the skin microbiome subset

Treatment:

Other: Lifestyle Questionnaire

Diagnostic Test: Skin microbiome collection

Other: Self-portrait image (Face and Hair)