1% Colloidal Oatmeal Cream/Baby Wash Regimen Improved Atopic Dermatitis in Pediatric Patients From First Use

October 2025 | Volume 24 | Issue 10 | 9095 | Copyright © October 2025


Published online September 29, 2025

Gabrielle Kosmoski BSa, Diana Friscia BAa, M. Catherine Mack PhDa, Laura M. Brooks MDb, Carrie W. Cobb MDb, Zoe D. Draelos MDc

aKenvue Brands LLC, Summit, NJ
bThe Education & Research Foundation, Inc., Lynchburg, VA
cDermatology Consulting Services, PLLC, High Point, NC

Abstract
Background and Objective: Atopic dermatitis (AD) affects 15% to 20% of children. Evidence supporting the effectiveness of colloidal oatmeal-based moisturizers in improving mild-to-moderate AD is accumulating. Data on use with a bathing routine, where compromised skin could be affected, is lacking. This study evaluated the effectiveness and tolerability of 1% colloidal oatmeal-containing cream and gentle baby wash in children with AD.
Methods: In this open-label, single-arm study of children 3 to 72 months old with mild-to-moderate AD, 1% colloidal oatmeal-containing cream was applied twice daily, and a gentle baby wash was used ≥3 times/week for 4 weeks. Primary endpoint: mean change from baseline at day 28 in the Eczema Area Severity Index (EASI) and Atopic Dermatitis Severity Index (ADSI) total scores. Adverse events (AEs), tolerability, skin barrier (SB), Infant Dermatitis Quality of Life (IDQoL), sleep (Brief Infant Sleep Questionnaire-Revised; BISQ-R), and pruritus were evaluated. Assessments were performed at baseline and on days 1, 3, 7, and 28.
Results: Twenty-nine of 31 enrollees completed the study. At all visits, improvements from baseline in EASI, ADSI, IDQoL, and pruritus were significant (P<0.05). SB significantly improved at most visits. Two AEs were reported and led to study discontinuation (papular rash; contact dermatitis).
Conclusions: The study regimen was effective and well-tolerated in this pediatric population with AD. Improvements occurred as early as day 1, with a rapid reduction in pruritus and increased well-being.

INTRODUCTION

Atopic dermatitis (AD), the most common chronic inflammatory skin disease, affects 15% to 20% of infants/children, with symptoms generally developing by 1 year of age.1 Pruritus and inflammatory lesions (typically on the infants'/children’s face, neck, and extensor regions) are characteristic symptoms.2 Pruritus may also be accompanied by burning and pain that lowers the infants’/children’s overall quality of life (QoL), including their emotional state and sleep quality, regardless of AD severity.3 Additionally, AD has a secondary impact on parents’/caregivers' QoL, due to increased caregiving responsibilities and psychological stressors (eg, anxiety, depression, and financial burden from long-term treatment/care).4-7

In AD, skin barrier dysfunction manifesting as reduced hydration and elevated transepithelial water loss (TEWL) across the stratum corneum (SC) is apparent in non-lesion and lesion skin, particularly in more severe disease.3,8 For all patients with AD, twice-daily emollient therapy is recommended to repair/support the skin barrier and help reduce flares.9 Colloidal oatmeal is a recognized, safe, well-tolerated, and effective ingredient with a long history of use for skin conditions;10,11 it is approved by the US Food and Drug Administration as an over-the-counter (OTC) skin protectant that helps relieve minor eczema-related irritation and itching.

Increasing clinical evidence regarding the use of colloidal oatmeal-based OTC moisturizers for adults and children with mild-to-moderate AD demonstrates efficacy and safety vs prescription nonsteroidal barrier creams.12-15 However, evidence in infants, toddlers, and young children is lacking, particularly in real-world settings incorporating a bathing routine, where it is important to use a mild/gentle, nondrying cleanser that maintains the skin barrier and pH without disrupting or drying out compromised skin. This study evaluated the effectiveness and tolerability of a skincare routine using a 1% colloidal oatmeal-containing cream and gentle baby wash in infants/children with AD.