Steroid-Free Over-the-Counter Eczema Skin Care Formulations Reduce Risk of Flare, Prolong Time to Flare, and Reduce Eczema Symptoms in Pediatric Subjects With Atopic Dermatitis

May 2015 | Volume 14 | Issue 5 | Original Article | 478 | Copyright © 2015

Teresa M. Weber PhD,a Frank Samarin MD,b Michael J. Babcock MD,c
Alexander Filbry PhD,d and Frank Rippke MDd

aUS Research and Development, Beiersdorf Inc, Wilton, CT
bMountaintop Dermatology, Colorado Springs, CO
cColorado Springs Dermatology Clinic, Colorado Springs, CO
dResearch and Development, Beiersdorf AG, Hamburg, Germany

Abstract

INTRODUCTION: Atopic dermatitis (AD) is a chronic skin condition associated with decreased barrier function resulting in periodic flare-ups of erythematous and pruritic lesions. Guidelines recommend daily treatment of atopic skin with emollient moisturizers for prevention of flares and maintenance of the flare-free state. This study evaluated the efficacy of 2 steroid-free, nonprescription eczema skin care formulations for reducing the risk of flare and relieving symptoms in infants and children with AD: Body Cream for the daily maintenance treatment of atopic skin and Flare Treatment for the treatment of atopic flares.
METHODS: After a 2-week washout period, subjects (N=45; mean age 3.5 years) were randomized to cleanser plus daily moisturizing with Body Cream (moisturizer group) or cleanser only (control group) for 6 months or until flare. Subjects experiencing flare received Flare Treatment for 4 weeks.
RESULTS: The incidence of flare was significantly lower in the moisturizer group compared with the control group (21% vs 65%; P=.006), while the median time to flare was shorter in the control group (28 vs >180 days). Risk of flare was reduced by 44.1% after 6 months of Body Cream application. Flare Treatment reduced overall eczema symptom severity at week 2 and week 4; 78.9% of flares had improved or cleared at week 4.
CONCLUSIONS: Body Cream reduced the incidence of flare and the time to flare, reinforcing guidelines that daily emollient therapy should be an integral part of the maintenance treatment plan for the prevention of disease flares. Body Cream and Flare Treatment are effective over-the-counter steroid-free options for management of AD in children.

J Drugs Dermatol. 2015;14(5):478-485.

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INTRODUCTION

Atopic dermatitis (AD) is a chronic skin condition affecting 1% to 3% of adults and 15% to 30% of children.1,2 It is characterized by dry, irritated skin with periodic flareups of lesions involving erythema, edema, and pruritus.2-4

The contemporary hypothesis of the etiology of AD consists of 2 opposing theories: the outside-in theory (barrier theory) and the inside-out theory (immune theory). The outside-in theory contends that a defective skin barrier function allows infection and transepidermal water loss (TEWL), leads to proinflammatory responses, provokes itching, and is exacerbated by subsequent scratching behaviors. The inside-out theory proposes that the barrier dysfunction results from an increased expression of proinflammatory signaling molecules, which then allows TEWL and infection to occur.5,6

Regardless of the underlying pathogenesis, both the barrier theory and immune theory highlight the central role the skin barrier plays in flare onset. Therefore, if the skin barrier function in AD patients can be maintained, there will be an associated reduction not only in the number of flares and degree of severity an individual experiences, but also in the frequency of eczematous flares an individual experiences over a given amount of time.

European and US guidelines recommend daily application of emollient moisturizers for the prevention and treatment of symptoms of AD.4,7, 8 Moisturizers should be an integral part of the maintenance treatment plan for the prevention of disease flares.9 Moisturizers help treat xerosis and counteract TEWL caused by a defective skin barrier, and in controlled clinical trials have been demonstrated to reduce symptoms of AD, particularly pruritus, erythema, fissuring, and lichenification.7 Topical corticosteroids are the primary prescription product used to control flare-ups of AD, providing anti-inflammatory benefits,4,7, 8,10 and are usually prescribed when good skin care and daily moisturizing have not been sufficient to heal lesions.7 However, topical steroids do

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