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

NCT07225166 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-11-25

No results posted yet for this study

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

OTHER

Instrumental Measurements

The following procedures will be conducted on the child subject: * Corneometer measurements * Tewameter measurements * Skin pH Meter measurements

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

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)

Sponsors & Collaborators

  • Kenvue Brands LLC

    lead INDUSTRY

Eligibility

Min Age
3 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-11-05
Completion
2025-11-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225166 on ClinicalTrials.gov