rienced an adverse event (AE) during the treatment phase. The
subject presented at the 2-week visit with worsening eczema
on the back, chest, and stomach, whereby the subject was withdrawn
from the study and treated with 1% hydrocortisone, and
the eczema subsequently resolved.
DISCUSSION
A functioning skin barrier protects the body from infection,
irritation, and TEWL. Characteristics of a healthy skin barrier
include adequate hydration; natural moisturizing factor, lipid,
and ceramide content; and an acidic pH. Barrier defects play
a central role in the pathogenesis of AD. Consequently, daily
moisturizing practices are important to support proper barrier
function that can protect the skin from excessive bacterial colonization
(especially by Staphylococcus aureus) and external
irritants that provoke and exacerbate flares.18 Daily moisturizing
improves skin hydration, limits TEWL,1 and can relieve pruritus,
19 helping to keep AD symptoms under control.
Reported rates of AD are high in children, and although approximately
70% of affected children outgrow their AD, their skin will
remain susceptible to irritation throughout their lives.1,2,10 The
baseline questionnaire revealed that 82.1% of subjects had 3 or
more flares in the year prior to the study. For treatment of their
child’s most recent flare, 26.7% of parents relied on advice from
their pediatrician and 2.2% from their dermatologists; however,
68.9% of respondents (n=45) reported that they did not seek
medical advice. This is not surprising, as it is unlikely that parents
would take their child to a physician for every flare. In addition,
60% of parents used a moisturizer to treat their child’s last flare.
These results reinforce the need for education on the use of
emollient moisturizers with proven efficacy to manage AD.
Due to the chronic, relapsing nature of AD, it is important to adopt
skin care practices that can help minimize flare incidence and
severity, including bathing with gentle cleansers and daily moisturizing
with product formulations that are optimized to address
the specific needs of atopic skin. Previous studies have examined
the efficacy and tolerability of the Body Cream and Flare
Treatment individually on adult and infant/child cohorts, but not
as a skin care regimen for the management of AD.16,17 In these
earlier studies, Body Cream and Flare Treatment were found to
significantly improve skin hydration and ameliorate AD symptom
severity. Both products were safe and well tolerated in all subjects.
This clinical study tested the efficacy and tolerability of Body
Cream and Flare Treatment when used in conjunction with a mild
cleansing body wash formulation. Use of Body Cream and cleanser
significantly reduced the incidence of flare compared with use
of cleanser only (21% vs 65%, P=.006). In addition, treatment with
Body Cream prolonged the flare-free interval for moisturizer group
subjects, likely by helping improve and maintain barrier function,16
validating Body Cream as a daily skin care product for the management
of eczema. In subjects who experienced flare, baseline
ADSI scores were notably higher for the control subjects than for
the subjects receiving Body Cream, suggesting a further benefit
of daily moisturizer use. Observed differences between groups in
time to flare, the percentage of subjects experiencing flare, and
the significant reduction in risk of flare reinforce the benefits of
daily emollient therapy with moisturizers that have demonstrated
clinical efficacy as a cornerstone in AD management.
Other studies of emollient treatment also support its use for the
management and prevention of AD. In a study design similar to
ours but conducted in adults, moisturizer (5% urea oil-in-water
emulsion) was applied daily to a cleared flare for 6 months or
left untreated.20 The differences between moisturizer and control
groups in the median time to flare (>180 days vs 30 days) and
percentage of subjects experiencing flare (68% vs 32%) were
similar to those in our study.20 (It should be noted that 5% urea
is not typically used for pediatric AD.) To further probe the relevance
of daily moisturization in AD, two prevention studies were
conducted in neonates with a family history of AD to determine
whether early treatment with emollient therapy could reduce the
risk of developing AD among high-risk neonates.21,22 Newborns
with either a parent or full sibling with AD were treated with daily
emollient therapy within 1 to 3 weeks of birth for 6 months or
were part of the control group that did not apply any topical products.
In both studies, there was a statistically significant reduction
in the relative risk of developing eczema of 32% to 50%.21,22
The study results also confirmed the efficacy of Flare Treatment
in reducing active eczema symptom severity in infants and children.
Flare Treatment was observed to be highly effective in
reducing symptom severity, without concomitant medication,
as demonstrated by significant decreases in ADSI scores from
baseline after week 2 and week 4 in the control group, indicating
the effectiveness of the acute therapy despite the lack of
pre-flare skin care with moisturizer.
