A 1% Colloidal Oatmeal Cream Alone is Effective in Reducing Symptoms of Mild to Moderate Atopic Dermatitis: Results from Two Clinical Studies

July 2017 | Volume 16 | Issue 7 | Original Article | 671 | Copyright © 2017

Toni Anne Lisante BA,a Chris Nunez PhD,b Paul Zhang PhD,c and Barbara M. Mathes MDd

aGlobal Scientific Engagement, Johnson & Johnson Consumer Inc., Skillman, NJ bMedical Affairs, Johnson & Johnson Consumer Inc., Skillman, NJ cBiostatistics, Johnson & Johnson Consumer Inc., Skillman, NJ dDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA

Abstract

BACKGROUND: The epidermal barrier in patients with atopic dermatitis (AD) is deficient in ceramides and cathelicidins. Such epidermal defects may be a trigger for AD, thereby encouraging research toward development of skin-barrier-targeted preventive strategies.

METHODS: Two single-center, single-arm clinical trials were conducted (study 1, age greater than equal to 8 years and study 2, greater than equal to 10 years) in patients with mild to moderate AD to evaluate the effects of an over-the-counter 1% colloidal oatmeal cream administered for 14 days. Study 1 assessed the Eczema Area and Severity Index (EASI) and Investigator’s Global Atopic Dermatitis Assessment (IGADA) on day 3, and itch severity using a Visual Analogue Scale (VAS) immediately after application as primary efficacy endpoints. In study 2, the primary efficacy endpoint was change from baseline in patients’ assessment of itch. Both studies assessed safety through adverse event (AE) recording.

RESULTS: Study 1: 29 patients were enrolled (mean age [range], 27.07 [8 –67]). Comparing to baseline, EASI, IGADA, and itch were improved after the application, and improvements were maintained until day 14. Improvements of greater than/equal to 20% over baseline were noted in 53.6% and 25.0% patients at day 3 for EASI and IGADA scores, respectively, and in 37.9% patients for itch score immediately after the product application. On day 14, these percentages were 82.8%, 62.1%, and 85.7%, respectively.

STUDY 2: 30 patients were enrolled (mean age [range], 32.9 [10-80]). Itch severity and EASI score were significantly improved after product application and improvements were maintained until day 14. Transepidermal water loss values were significantly reduced and skin hydration was significantly increased at all assessment time points. No adverse events (AEs) were reported in study 2 and 2 AEs were reported by 1 patient in study 1.

CONCLUSIONS: The colloidal oatmeal cream was well tolerated and clinically effective in patients with mild to moderate AD.

J Drugs Dermatol. 2017;16(7):671-676.

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INTRODUCTION

Atopic dermatitis (AD), a chronic skin condition characterized by pruritus, inflammation, and acute are-ups of eczematous lesions over dry skin,1 affects approximately 15% to 20% children and approximately 1% to 3% adults worldwide,2 with slightly higher rates of incidence in the United States (children, 10%–25%; adults, 3%–5%).3,4 The wide range of clinical manifestations, the visible nature of the disease, and the intense itching associated with sleep disturbances, significantly affects patients’ quality of life and is a burden on healthcare resources.4 The guidelines of the American Academy of Dermatology and the Joint Task Force representing the American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma & Immunology (ACAAI), and the Joint Council of Allergy, Asthma and Immunology recommend the use of topical agents, such as moisturizers, as a first-line treatment in patients with AD. For AD uncontrolled with moisturizers, topical corticosteroids and calcineurin inhibitors may be instituted. Deficiency in ceramides and antimicrobial peptides, such as cathelicidins, within the skin of AD patients leads to increased transepidermal water loss (TEWL) and easier penetration of allergens or microbes into the skin.4,5 Recent ndings suggest that these epidermal defects may be a trigger for AD;6 hence, research aimed at the development of skin-barrier-targeted preventive strategies has been encouraged. Strong evidence supports the use of moisturizers to ameliorate AD symptoms and improve skin hydration and barrier function.7-9 Although various prescription emollients are currently available, studies have shown that over-the-counter (OTC) moisturizers are equally ef cacious and more cost-effective.10,11 The limitations of topical steroids, particularly in children with AD, further highlight the need for nonpharmacological treatment

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