Washout Phase Baseline Questionnaire
The eczema history questionnaire completed at baseline
showed that 78% of subjects had flared 3 to 4 times in the previous
12 months, while 18% had flared 1 to 2 times during this
time period. When asked about the treatment of the last flare
their child had experienced, the majority of parents/guardians
responded that they managed their child’s treatment on their
own (69%), while the remainder visited a pediatrician (27%),
dermatologist (2%), or a general practitioner (2%). The most
common treatments used, as reported by parents/guardians,
were moisturizer (60%) or 1% non-prescription hydrocortisone
(40%) (Figure 3A). Overall, 44% of parents were not concerned
about using prescription products to treat their child’s eczema,
while 40% did not use prescription products to treat their
child’s eczema (Figure 3B).
Maintenance Phase Assessments
A total of 19 subjects were confirmed to have eczema flares
during the maintenance phase. Only 4 of 19 subjects (21%)
flared in the moisturizer group, vs 15 of 23 (65%) in the control
group, a statistically significant difference (P=.006; Figure 4).
In addition, control group subjects flared earlier (mean 27.8
days) than the moisturizer group subjects (55 days) (Table 2).
Considering all subjects who completed the study (n=43), the
median time to flare was 28 days for the control group and
more than 180 days for the moisturizer group (Table 2).
The differences between groups in time to flare and the number
of subjects who experienced flare were statistically significant
(P<.05) (Figure 5). At the end of the 6-month maintenance
phase, 78.9% of subjects in the moisturizer group remained
flare-free, compared with 34.8% of the control group, indicating
a 44.1% reduction in risk of flare after 6 months of daily
application of Body Cream. The overall hazard ratio for risk of
flare in the maintenance phase was 4.74 (95% CI, 1.57-14.38).
Treatment Phase Flare Assessments
The 19 subjects who flared during the maintenance phase entered
the 4-week treatment phase. Application of Flare Treatment
