gentle cleanser was used for all bathing, and bathing time was
limited to less than 8 minutes and rinsing with lukewarm water.
No other skin care products were permitted.
For the maintenance phase, the moisturizer group used Body
Cream on the entire body at least once per day in addition to
the cleanser, while the control group continued with cleanser
only (no moisturizer) for 6 months, or until a flare occurred.
Subjects who developed a flare entered the treatment phase.
Flare Treatment was applied to the affected area each morning
and evening, or more often as necessary, for 4 weeks.
After 4 weeks of Flare Treatment, subjects ceased participation
in the study.
Assessments
Moisturizer and control groups were compared for the number
of subjects who flared in each group and for the time
to flare in each group (including mean, median, minimum,
and maximum days to flare). Flares were assessed at all
treatment phase visits by clinical grading of eczema symptoms
of lesions, including erythema, pruritus, exudation,
excoriation, and lichenification (0=none, 1=mild, 2=moderate,
3=severe), and by the Atopic Dermatitis Severity Index
(ADSI, 0-15 scale), the sum of the component eczema symptom
scores. At weeks 2 and 4 of treatment, the degree of
improvement was graded by the investigator according the
following scale: 1=markedly worse, 2=moderately worse,
3=no change, 4=moderate improvement, 5=marked improvement,
6=clear/almost clear.
Global tolerability was graded by the investigator from 1=excellent
to 4=poor at visit 2 (end of washout phase) and visit 3
(week 4 of maintenance phase). For subjects who flared, global
tolerability of flare treatment was assessed at weeks 2 and 4 of
the treatment phase.
Statistics
Differences between groups in number and percentage of subjects
who flared were analyzed using the Fisher exact test. Significant
difference in time to flare between groups was calculated using
the log-rank test. Change in ADSI scores between baseline, week
2, and week 4 of the treatment phase and between groups were
tested for significance using the Wilcoxon signed rank test.
Global tolerability data analysis compared favorable (excellent
and good) vs unfavorable (fair and poor) tolerability using a
binomial (sign) test (null hypothesis). All statistical tests were
2-sided at a significance level α of .05 and were performed using
SAS software version 9.3 (SAS Institute, Cary, NC).
RESULTS
Of the 45 subjects who were enrolled at baseline, 43 completed
the study. Two subjects who flared discontinued during
the treatment phase (Figure 2). Subjects ranged in age from 7
months to 11 years 5 months (mean, 3.5 years) (Table 1).
