Sensitive SkinNCT07225166
A Clinical Investigation Into the Association of an Impaired Skin Barrier and Infant and Toddler Sensitive Skin
An observational study of Sensitive Skin and Non-sensitive Skin, run by Kenvue Brands LLC at 1 site in United States.
Trial summary
This is a Single center, evaluator-blinded clinical trial that intends to • Evaluate differences in TEWL measurements between parent-reported sensitive skin subjects and healthy subjects (subjects without sensitive skin) • Evaluate differences in skin capacitance between parent-reported sensitive skin subjects and… Read more about this study
- Who is it for?
- Ages 3 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin, Non-sensitive Skin
- What is being tested?
- Expert Clinical Grading, Instrumental Measurements and Parental Questionnaires
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 5 Nov 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 3 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Babies aged 3 to 36 months with either having HCP-diagnosed sensitive skin or parent-reported sensitive skin. Babies aged 3 to 36 months who have never been diagnosed with sensitive skin by a HCP nor have parent-reported sensitive skin.
Who may be able to join
- Subject pairs must meet all the following inclusion criteria for enrollment into the study (only one eligible child subject may be enrolled with any one parent subject).
- Parent subject and child subject:
- Generally, in good health based on medical history reported by the parent subject.
- Intends to complete the study and is willing and able to follow the subject responsibilities and undergo necessary testing procedures (tape stripping for baby subjects) and answer multiple questionnaires.
- Child subject:
- Males and females aged 3 months-old up to 36 months-old (inclusive), targeting to complete with:
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- Sensitive Skin Cohort (cohort 1): at least 30 child subjects in the 3 months-old up to 36 months-old range with 100% HCP diagnosed sensitive skin or parent-reported sensitive skin, and as defined as parent subjects who respond "Yes" to the Yes/No question "Do you believe your child has sensitive skin?"
- Non-Sensitive Skin Cohort (cohort 2): at least 30 child subjects in the 3 months-old up to 36 months-old age range with 100% having normal skin, has never been diagnosed with sensitive skin by a HCP, and as defined as parent subjects who respond "No" to the Yes/No question "Do you believe your child has sensitive skin?"
- Has parent-reported natural skin tone "pale/fair to light white," "white to light beige," "beige to light tan/light olive," "medium tan/medium olive to light brown," "medium brown to dark brown," "darkest brown to darkest black", with every effort made to complete with at least 1 child subject for each skin tone per cohort.
- Parent subject:
- Is at least 18 years old.
- Is the primary caregiver and legal guardian of the child subject and is willing and able to present proof of legal guardianship (e.g. birth certificate/hospital discharge paperwork along with valid ID of legal guardian, etc.).
- Is able to read, write, speak, and understand English.
- Has signed the Consent for Photo Release and ICD including a Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- Intends to complete the study and is willing and able to follow all study instructions.
- Parent subjects must agree to discontinue child's current face/body washes and face/body lotions for 24 hours prior to their study visit.
Who cannot join
- Child Subject:
- Is using Systemic or topical over-the-counter (OTC) or prescription medications that, in the Investigator's judgement, will affect skin condition or interfere with study evaluation. (Use of acetaminophen as needed is acceptable if it was instructed by the baby's pediatrician. Child vitamins are allowed.)
- Is using topical steroids within 2 weeks before Visit 1.
- Has Type 1 or Type 2 diabetes(reported by the parent) or is taking insulin or another anti-diabetic medication.
- Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
- Immunosuppressive or steroidal drugs within 2 months before Visit 1
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- Non-steroidal anti-inflammatory drugs within 5 days before Visit 1
- Antihistamines within 2 weeks before Visit 1
- If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the Investigator should be consulted to consider the impact of the specific medication on subject safety and/or the study results.
- Has a history of or a concurrent health/other condition/situation which may put the child subject at significant risk, confound the study results, or interfere significantly with the subject pair's participation in the study, as determined by the Investigator or designee.
- Has a history of skin cancer.
- Is simultaneously participating in another study involving product usage or skin sampling for the duration of the study or has participated in another study involving product usage or skin sampling within 14 days prior to Visit 1.
- Has used new facial and body products and/or brands two weeks prior to Visit 1.
- Is an immediate family member of the Investigator, Study Site, or Sponsor.
- Presents with a skin condition that may confound the study results, increase risk to the subject, or influence the outcome of the study (e.g., psoriasis, eczema, atopic dermatitis, cutaneous xerosis, or active skin cancer), as determined by the Investigator or designee.
- Parent subject:
- Is simultaneously participating in another study.
- Is an employee/contractor of the Study Site or Sponsor or immediate family member of the PI, Study Site, or Sponsor.
Trial locations and contacts
1 site in 1 country.
United States1 site
SGS North America, Inc. - Dallas Research Center
Richardson, Texas, 75081
About this study
This is a Single center, evaluator-blinded clinical trial that intends to • Evaluate differences in TEWL measurements between parent-reported sensitive skin subjects and healthy subjects (subjects without sensitive skin) • Evaluate differences in skin capacitance between parent-reported sensitive skin subjects and healthy subjects (subjects without sensitive skin). A sufficient number of subjects pairs (comprised of a parent subject and a child subject) will be enrolled to complete the study with at least 60 subject pairs (30 subject pairs per group).
- Conditions
- Sensitive Skin, Non-sensitive Skin
- Being tested
- Expert Clinical Grading, Instrumental Measurements, Parental Questionnaires, Biomarker Measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert Clinical GradingOther
The expert grader will separately assess each child subject's face and body (right and left volar forearms combined, right and left leg combined, torso) for each of the parameters below according to the following 4-point scales (half points are allowed):
- Visual Dryness, Tactile Surface Roughness, Erythema.
Instrumental MeasurementsOther
The following procedures will be conducted on the child subject:
- Corneometer measurements
- Tewameter measurements
- Skin pH Meter measurements
Parental QuestionnairesOther
The following questionnaires will be given to the parent subject to answer:
- Questionnaire: Reaction to Environmental, Chemical, and Mechanical Stimuli
- Questionnaire: Medical/Family History Questionnaire
- Questionnaire: Bathing and Skincare Routines
Biomarker MeasurementsOther
The following procedures will be conducted on the child subject:
- D-Squame skin sampling (for corneocyte visualization and lipid analysis)
- Microbiome sampling
- D-Squame skin sampling (for inflammatory proteins)
| Study group | Role | What they receive |
|---|---|---|
| Sensitive Skin Group | * 5-8 babies that are 3 to 6 months old
* At least 5 babies that are 7 to 12 months old
* At least 10 toddlers that are 13 to 36 months old Receives: Other: Expert Clinical Grading; Other: Instrumental Measurements; Other: Parental Questionnaires; Other: Biomarker Measurements | |
| Non-Sensitive Skin Group | * 5-8 babies that are 3 to 6 months old
* At least 5 babies that are 7 to 12 months old
* At least 10 toddlers that are 13 to 36 months old Receives: Other: Expert Clinical Grading; Other: Instrumental Measurements; Other: Parental Questionnaires; Other: Biomarker Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneometer measurement results
Higher values indicate greater hydration of the skin
Measured: Visit 1 (Day 0)
Tewameter measurement results
Lower values reflect a reduced rate of water loss (improved skin barrier function)
Measured: Visit 1 (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start1 Oct 2025
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive SkinStudies 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
- 60 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
- NCT07225166
- Sponsor's protocol ID
- CS2025SK100263
- Status last verified
- 7 Nov 2025
- First submitted
- 3 Nov 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Into the Association of an Impaired Skin Barrier and Infant and Toddler Sensitive Skin
- ClinicalTrials.gov ID
- NCT07225166
- Acronym / sponsor ID
- CS2025SK100263
- Conditions
- Sensitive Skin, Non-sensitive Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kenvue Brands LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 5 Nov 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 Single center, evaluator-blinded clinical trial that intends to • Evaluate differences in TEWL measurements between parent-reported sensitive skin subjects and healthy subjects (subjects without sensitive skin) • Evaluate differences in skin capacitance between parent-reported sensitive skin subjects and healthy subjects (subjects without sensitive skin). A sufficient number of subjects pairs (comprised of a parent subject and a child subject) will be enrolled to complete the study with at least 60 subject pairs (30 subject pairs per group).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensitive Skin Group | – | Other: Expert Clinical Grading, Other: Instrumental Measurements, Other: Parental Questionnaires, Other: Biomarker Measurements* 5-8 babies that are 3 to 6 months old * At least 5 babies that are 7 to 12 months old * At least 10 toddlers that are 13 to 36 months old |
| Non-Sensitive Skin Group | – | Other: Expert Clinical Grading, Other: Instrumental Measurements, Other: Parental Questionnaires, Other: Biomarker Measurements* 5-8 babies that are 3 to 6 months old * At least 5 babies that are 7 to 12 months old * At least 10 toddlers that are 13 to 36 months old |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Babies aged 3 to 36 months with either having HCP-diagnosed sensitive skin or parent-reported sensitive skin. Babies aged 3 to 36 months who have never been diagnosed with sensitive skin by a HCP nor have parent-reported sensitive skin.
Key inclusion criteria (16 listed)
- Subject pairs must meet all the following inclusion criteria for enrollment into the study (only one eligible child subject may be enrolled with any one parent subject).
- Generally, in good health based on medical history reported by the parent subject.
- Intends to complete the study and is willing and able to follow the subject responsibilities and undergo necessary testing procedures (tape stripping for baby subjects) and answer multiple questionnaires.
- Males and females aged 3 months-old up to 36 months-old (inclusive), targeting to complete with:
- Sensitive Skin Cohort (cohort 1): at least 30 child subjects in the 3 months-old up to 36 months-old range with 100% HCP diagnosed sensitive skin or parent-reported sensitive skin, and as defined as parent subjects who respond "Yes" to the Yes/No question "Do you believe your child has sensitive skin?"
Key exclusion criteria (18 listed)
- Is using Systemic or topical over-the-counter (OTC) or prescription medications that, in the Investigator's judgement, will affect skin condition or interfere with study evaluation. (Use of acetaminophen as needed is acceptable if it was instructed by the baby's pediatrician. Child vitamins are allowed.)
- Is using topical steroids within 2 weeks before Visit 1.
- Has Type 1 or Type 2 diabetes(reported by the parent) or is taking insulin or another anti-diabetic medication.
- Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
- Has a history of or a concurrent health/other condition/situation which may put the child subject at significant risk, confound the study results, or interfere significantly with the subject pair's participation in the study, as determined by the Investigator or designee.
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 |
|---|---|---|
| Expert Clinical GradingThe expert grader will separately assess each child subject's face and body (right and left volar forearms combined, right and left leg combined, torso) for each of the parameters below according to the following 4-point scales (half points are allowed): - Visual Dryness, Tactile Surface Roughness, Erythema. | Other | Non-Sensitive Skin Group, Sensitive Skin Group |
| Instrumental MeasurementsThe following procedures will be conducted on the child subject: * Corneometer measurements * Tewameter measurements * Skin pH Meter measurements | Other | Non-Sensitive Skin Group, Sensitive Skin Group |
| Parental QuestionnairesThe following questionnaires will be given to the parent subject to answer: * Questionnaire: Reaction to Environmental, Chemical, and Mechanical Stimuli * Questionnaire: Medical/Family History Questionnaire * Questionnaire: Bathing and Skincare Routines | Other | Non-Sensitive Skin Group, Sensitive Skin Group |
| Biomarker MeasurementsThe following procedures will be conducted on the child subject: * D-Squame skin sampling (for corneocyte visualization and lipid analysis) * Microbiome sampling * D-Squame skin sampling (for inflammatory proteins) | Other | Non-Sensitive Skin Group, Sensitive Skin Group |
Primary outcome
Corneometer measurement results
Time frame: Visit 1 (Day 0)
Higher values indicate greater hydration of the skin
Tewameter measurement results
Time frame: Visit 1 (Day 0)
Lower values reflect a reduced rate of water loss (improved skin barrier function)
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 25 Nov 2025.
- 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 Sensitive Skin and Non-sensitive Skin, 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 16 inclusion and 18 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 25 Nov 2025. 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?
Corneometer measurement results (time frame: Visit 1 (Day 0)). The study lists 2 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 25 Nov 2025.