Skin AgingNCT07193290
A Pilot Study to Evaluate the Expanded Reach of Decentralized Digital Skin Health Clinical Studies
An observational study of Skin Aging and Hair Care, run by Kenvue Brands LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Hair Care, Skin Microbiome
- What is being tested?
- Lifestyle Questionnaire, Self-portrait image (Face and Hair) and Skin microbiome collection
- How many people
- 1,027 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population is 18- to 65-year-old, healthy female subjects.
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lifestyle Questionnaire, Self-portrait image (Face and Hair), Skin microbiome collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle QuestionnaireOther
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 collectionDiagnostic test
Subjects randomly assigned in the skin microbiome subset will complete the skin microbiome collection
| Study group | Role | What they receive |
|---|---|---|
| Non-Skin Microbiome Subset | 18- to 65-year-old female subjects. Receives: 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 Receives: Other: Lifestyle Questionnaire; Other: Self-portrait image (Face and Hair); Diagnostic Test: Skin microbiome collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks post Last Subject's remote visit
Secondary outcomes (2)
Questionnaire results compared across skin tone
The lifestyle questionnaire results will be summarized by either descriptive analysis or frequency by Monk Skin tone 1 to 10.
Measured: 4 weeks post Last Subject's remote visit
Questionnaire results compared across age groups
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.
Measured: 4 weeks post Last Subject's remote visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start13 May 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,027 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenvue Brands LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193290
- Sponsor's protocol ID
- CS2024SK100177
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Expanded Reach of Decentralized Digital Skin Health Clinical Studies
- ClinicalTrials.gov ID
- NCT07193290
- Acronym / sponsor ID
- CS2024SK100177
- Conditions
- Skin Aging, Hair Care, Skin Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Kenvue Brands LLCIndustry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Skin Microbiome Subset | – | Other: Lifestyle Questionnaire, Other: Self-portrait image (Face and Hair)18- to 65-year-old female subjects. |
| Skin Microbiome Subset | – | Other: Lifestyle Questionnaire, Other: Self-portrait image (Face and Hair), Diagnostic Test: Skin microbiome collection18- to 65-year-old female subjects randomly assigned in the skin microbiome subset |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is 18- to 65-year-old, healthy female subjects.
Key inclusion criteria (10 listed)
- 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:
- Lives within an Inner City, Urban, Suburban, or Rural community type (as determined by self-report or provided zip code), targeting to complete:
- 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.).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle QuestionnaireAll subjects will complete the lifestyle questionnaire | Other | Non-Skin Microbiome Subset, Skin Microbiome Subset |
| Self-portrait image (Face and Hair)All subjects will take one self-portrait image of their face and hair | Other | Non-Skin Microbiome Subset, Skin Microbiome Subset |
| Skin microbiome collectionSubjects randomly assigned in the skin microbiome subset will complete the skin microbiome collection | Diagnostic test | Skin Microbiome Subset |
Primary outcome
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.
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.
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.
2 secondary outcomes
Questionnaire results compared across skin tone
Time frame: 4 weeks post Last Subject's remote visit
Questionnaire results compared across age groups
Time frame: 4 weeks post Last Subject's remote visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Aging and Hair Care, run by Kenvue Brands LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interaction efficiency (contacted vs. enrolled) (time frame: 4 weeks post Last Subject's remote visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.