NCT07225166

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Kenvue Brands LLC · Industry
• Sex: All
• Age: 3 Months – 36 Months
• Healthy volunteers: Accepted

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).

Conditions

• Sensitive Skin
• Non-sensitive Skin

Interventions

Type	Name	Description
OTHER	Expert Clinical Grading	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.
OTHER	Instrumental Measurements	The following procedures will be conducted on the child subject: * Corneometer measurements * Tewameter measurements * Skin pH Meter measurements
OTHER	Parental Questionnaires	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
OTHER	Biomarker Measurements	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)

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-11-05
• Completion: 2025-11-05
• First posted: 2025-11-05
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States