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

NCT07193290 | Completed

• 1 other identifier: CS2024SK100177
• Study Type: observational
• Target: 1,027
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging; Hair Care; Skin Microbiome

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Questionnaire results compared across skin tone

  4 weeks post Last Subject's remote visit

• Questionnaire results compared across age groups

  4 weeks post Last Subject's remote visit

Study Arms (2)

Non-Skin Microbiome Subset

18- to 65-year-old female subjects.

Other: Lifestyle Questionnaire; Other: Self-portrait image (Face and Hair)

Skin Microbiome Subset

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

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

Interventions

Self-portrait image (Face and Hair) OTHER

All subjects will take one self-portrait image of their face and hair

Non-Skin Microbiome Subset; Skin Microbiome Subset

Skin microbiome collection DIAGNOSTIC_TEST

Subjects randomly assigned in the skin microbiome subset will complete the skin microbiome collection

Skin Microbiome Subset

Lifestyle Questionnaire OTHER

All subjects will complete the lifestyle questionnaire

Non-Skin Microbiome Subset; Skin Microbiome Subset

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population is 18- to 65-year-old, healthy female subjects.

You may qualify if:

• Self-reported Monk skin type 1 to 10, targeting to complete at least 100 subjects for each Monk skin type.
• to 65 years old, targeting to complete:
• to 40-year-old age range: at least 50 subjects within each Monk type
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kenvue Brands LLC: lead

Study Sites (1)

Laina Enterprises, Inc.

Apopka, Florida, 32712, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 25, 2025
• Study Start: May 13, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)