resulted in an overall reduction of eczema symptom severity at
all time points (Figure 6). Pruritus and excoriation symptoms at
flare onset were more severe in control group subjects, although
this comparison was not statistically significant. Treatment significantly
improved ADSI component scores in the control group
at weeks 2 and 4 (P<.05) for all symptoms except exudation.
ADSI scores indicated improvements in symptom severity for
the moisturizer group subjects; however, statistical significance
could not be determined due to the small sample size (n=4).
Flare Treatment improved overall ADSI scores in the moisturizer
group by 49.9% at week 2 and 84.2% at week 4 compared with
baseline; however, significance could not be determined due to
the small sample size. For the control group, ADSI scores improved
after week 2 by 49.7% (P<.05) and by 66.7% after week 4 (P<.05)
compared with baseline (Figure 7). There was no significant difference
between groups for treatment effect on overall ADSI scores.
According to investigator assessment of flare improvement in
the intent-to-treat population, 73.7% of flares showed moderate
or marked improvement or had completely cleared at week 2,
while 78.9% had improved or cleared at week 4.
Tolerability
Subject tolerability was assessed as either good or excellent for
all tested formulations. One subject in the control group expe-
