CompletedNot Applicable

A Clinical Investigation Into the Association of an Impaired Skin Barrier and Infant and Toddler Sensitive Skin

United States60 participantsStarted 2025-10-01

Plain-language 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 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).

Who can participate

Age range

3 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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.
. 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.).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Corneometer measurement results

Timeframe: Visit 1 (Day 0)

Tewameter measurement results

Timeframe: Visit 1 (Day 0)

Trial details

NCT IDNCT07225166

SponsorKenvue Brands LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11-05

View on ClinicalTrials.gov More Sensitive Skin trials

Plain-language summary

Who can participate

Age range

3 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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.
. 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.).

A Clinical Investigation Into the Association of an Impaired Skin Barrier and Infant and Toddler Sensitive Skin

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Clinical Investigation Into the Association of an Impaired Skin Barrier and Infant and Toddler Sensitive Skin

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria