Journal of drugs in dermatology : JDD · 2025
1% Colloidal Oatmeal Cream/Baby Wash Regimen Improved Atopic Dermatitis in Pediatric Patients From First Use.
СтатьяКлиническое исследованиеНазвание и аннотация: Перевод в очереди
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Kosmoski Gabrielle, Friscia Diana, Mack M Catherine, Brooks Laura M, Cobb Carrie W, Draelos Zoe D
Аннотация
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.
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.