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

NCT ID: NCT07193290

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1027 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-13

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Aging Hair Care Skin Microbiome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Non-Skin Microbiome Subset

18- to 65-year-old female subjects.

Lifestyle Questionnaire

Intervention Type OTHER

All subjects will complete the lifestyle questionnaire

Self-portrait image (Face and Hair)

Intervention Type OTHER

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

Skin Microbiome Subset

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

Lifestyle Questionnaire

Intervention Type OTHER

All subjects will complete the lifestyle questionnaire

Self-portrait image (Face and Hair)

Intervention Type OTHER

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

Skin microbiome collection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Lifestyle Questionnaire

All subjects will complete the lifestyle questionnaire

Intervention Type OTHER

Self-portrait image (Face and Hair)

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

Intervention Type OTHER

Skin microbiome collection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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:

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kenvue Brands LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laina Enterprises, Inc.

Apopka, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CS2024SK100177

Identifier Type: -

Identifier Source: org_study_id