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Article

A 1% colloidal oatmeal OTC cream is clinically effective for the management of mild to moderate atopic dermatitis in Black or African American children

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Article: 2241587 | Received 09 May 2023, Accepted 22 Jul 2023, Published online: 18 Aug 2023
 

Abstract

Background

The efficacy and safety of an over-the-counter (OTC) 1% colloidal oatmeal cream versus a ceramide-based prescription barrier cream in children with mild-to-moderate atopic dermatitis (AD) were previously described.

Objectives

Here, findings are reported for the Black/African American subgroup.

Methods

Patients were randomized to 1% oatmeal cream or prescription barrier cream twice daily or as needed for three weeks. Assessments included Eczema Area and Severity Index (EASI) scores, Investigator’s Global Atopic Dermatitis Assessment (IGADA) scores, and patients’/caregivers’ assessment of eczema signs and symptoms.

Results

Overall, 49 Black/African American children aged 2–15 years with mild/moderate AD were included. At week 3, mean (SD) changes from baseline in EASI scores were −2.4 (1.7) with 1% oatmeal cream and −2.1 (2.3) with barrier cream; improvements were observed from week 1. At week 3, mean (SD) changes from baseline in IGADA scores were −0.6 (0.7) and −0.7 (0.6), respectively. Improvements in subjective ratings of signs/symptoms of eczema were observed. Both study treatments were well tolerated.

Conclusion

OTC 1% oatmeal cream was at least as effective and safe as prescription barrier cream in this population, providing a novel, fast-acting, and cost-effective option for the symptomatic treatment of mild-to-moderate AD in Black/African American children.

Acknowledgements

The authors thank Paul Zhang for his contributions. Medical writing assistance was provided by Stuart Murray, MSc, of Evidence Scientific Solutions and funded by Johnson & Johnson Consumer Inc. a subsidiary of Kenvue.

Disclosure statement

Toni Anne Lisante and Menas Kizoulis are employees of Johnson & Johnson Consumer Inc. a subsidiary of Kenvue. Christopher Nuñez is an employee of Janssen Global Services, LLC. Corey Hartman serves as a consultant for Johnson & Johnson, Procter & Gamble, Scientis, Unilever, and L’Oréal; conducts clinical trials for Galderma, AbbVie, Revision Skincare, Scientis, and SkinBetter; and serves as a speaker for Johnson & Johnson, Skinceuticals, Allergan, Galderma, Scientis, and Revision Skincare.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Additional information

Funding

This study was not part of a grant. The work was funded by Johnson & Johnson Consumer Inc. a subsidiary of Kenvue.