A novel daily moisturizing cream for effective management of mild to moderate Atopic Dermatitis in infants and children

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1 TM Weber PhD 1, F Samarin MD 3, M Babcock MD 2, A Filbry PhD 4, C Arrowitz 1, F Rippke MD 4 1 Beiersdorf Inc., Wilton CT, USA 2 Mountaintop Dermatology, Colorado Springs CO, USA 3 Colorado Springs Dermatology Clinic, Colorado Springs CO, USA 4 Beiersdorf AG, Hamburg, Germany Background Atopic Dermatitis (AD) results in recurring flares of lesions that exhibit symptoms including xerosis, pruritus, erythema, edema, excoriations, and lichenification. Lesion or flare development is known to be associated with impaired skin barrier function in the stratum corneum. Aside from genetic and environmental factors that underlie the pathogenesis of AD, atopic skin has been found to be deficient in certain skin lipids and natural moisturizing factors that contribute to proper barrier function. Expert guidelines recommend daily emollient therapy to help repair the compromised barrier and help reduce the incidence of flare-ups. Daily application of an emollient cream is of particular importance for infants and children in order to limit the use of corticosteroids, which can damage skin with prolonged use. Further- Fig. 1 Parental concerns on treatment for acute AD flares Percentage of parents/guardians agreeing (more than one response allowed). Concerned about using prescription treatments Not concerned about frequently using whatever my doctor prescribes 1% hydrocortisone or other OTC products topical steroids prescribed by my doctor Antibiotics prescribed by my doctor other prescribed medicines more, parents have shown an aversion to using such medications whether it is overthe-counter (OTC) steroid treatments or medications prescribed by their family physician (Figure 1). 4.4% 4.4% 6.7% 13.3% % 1 5 Support provided by

2 Methods This single-center, randomized clinical study tested the efficacy of a novel OTC daily moisturizing Body Cream formulated for eczema, to help reduce the incidence of flares in infants and children during a 6 month period. This commercially available OTC formulation includes 1% colloidal oatmeal (skin protectant active ingredient), ceramide NP, licochalcone A, and glycerin in an oil-in-water formulation, to moisturize and soothe the skin. Objective Test the efficacy of the Body Cream formula to reduce AD flare incidence in infants and children over a 6-month period. Children 7 to 137 months with confirmed AD but no active flares at enrollment were recruited. Subjects (n=45, Table 1) were randomly assigned to either a Moisturizer group (n=21) or Control group (n=24). All subjects participated in a 2 week, standardized washout phase, ceasing all other topical treatments, using only an assigned mild-cleanser for all bathing and cleansing purposes. During the washout period, three subjects flared (1 control group; 2 moisturizer group) and were removed from the study. Table 1 All Subjects Moisturizer Group Control Group N* Mean age (months) Min. age Max. age Median age Male 53.3% (24) 61.9% (13) 45.8 (11) Female 46.7% (21) 38.1% (8) 54.2% (13) American Indian or Alaska Native 2.2% (1) 0. (0) 4.2% (1) Black or African American 15.6% (7) 14.3% (3) 16.7% (4) Hispanic or Latino 13.3% (6) 19. (4) 8.3% (2) White 44.4% (20) 33.3% (7) 54.2% (13) Mixed 24.4% (11) 33.3% (7) 16.7% (4) * Includes 2 discontinued subjects included in the ITT population. 2 5

3 After the washout period, the Control group (n=23) used only cleanser, while the Moisturizer group (n=19) continued cleanser and began treatment with the Body Cream twice daily for the duration (6 months) or until a flare occurred. Questionnaires were given at week 4 to evaluate parents/guardians perceptions of the Body Cream (Figure 2), or mild-cleanser for the control group (data not included). After week 4, caregivers were reminded every 2 weeks to continue respective treatments and report to the clinic immediately should their child flare. Flare events were recorded for each group, time-to-flare was Fig. 2 Moisturizer Group Self-Assessment* Questionnaire * assessed by parents/guardian with input from child if capable Week 4; n=19... provides effectively daily skin care for my child s eczema... keeps my child s skin soft and smooth... effectively moisturized my child s skin measured from the start of the treatment period to flare onset. Differences in the number of subjects that flared and the distribution of the time-to-flare between groups were analyzed gentle and mild on the skin... moisturizer help control my child s dry/itchy skin %... improves the condition of my child s skin 94.7% Three subjects data omitted from main analysis, flared during washout.... protects skin from dryness and itching 84.2% Agree Disagree 3 5

4 Results After the 6 month trial duration, 4 of 19 subjects in the Moisturizer group experienced a flare, vs. 15 of 23 subjects in the Control group (p=0.006). Additionally, the Control group experienced flares sooner (day 1) than the Moisturizer group (day 28). The mean time-to-flare (of those who flared) for the Control group was 27.8 days vs. 55 days for the Moisturizer group. A Kaplan-Meier plot was generated for the Control group vs. the Moisturizer group, and from this, a hazard ratio of 4.74 was calculated (Figure 3). Fig. 3 Effect of Daily Moisturization on Time-to-flare (TTF); Moisturizer Group Vs. Control Group Differences in TTF between the Moisturizer and Control groups were statistically significant (p<0.05) % of flare-free subjects Moisturizer i Group Control Group Study duration (180 days) 4 5

5 Conclusion Efficacy of this novel OTC moisturizing Body Cream to help maintain a properly functioning skin barrier was strongly indicated by a significantly lower incidence of flares in the Moisturizer group compared with the Control (p=0.006). Furthermore, the differences in flare incidence, the minimum time-to-flare, and mean time-to-flare between the two study groups highlights the importance of daily emollient therapy in AD management. These results confirm that the test Body Cream offers a safe, realistic, daily treatment for infants and children, reducing the reliance on topical steroid treatments, which can have adverse cutaneous effects as a result of long-term usage. 5 5