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

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%; <em>P</em>=.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.