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OpenTrials
Completed

NCT Number: NCT07193290

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

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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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Laina Enterprises, Inc.

Apopka, Florida, 32712, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Questionnaire

Other

All subjects will complete the lifestyle questionnaire

Self-portrait image (Face and Hair)

Other

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

Skin microbiome collection

Diagnostic Test

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

Primary outcomes

  1. Interaction efficiency (contacted vs. enrolled)

    Time frame: 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.

  2. Percent completion of subject self-taken images

    Time frame: 4 weeks post Last Subject's remote visit

    The number and percentage of subjects who successfully completed the self-taken images.

  3. Percent completion of subjects participating in bio-sampling subset

    Time frame: 4 weeks post Last Subject's remote visit

    The number and percentage of subjects who successfully completed the bio-sampling procedures.

Secondary outcomes

  1. Questionnaire results compared across skin tone

    Time frame: 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.

  2. Questionnaire results compared across age groups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kenvue Brands LLC

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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