In a prospective, randomized, investigator-blinded, multicentre study, 121 patients with moderate-to-severe atopic dermatitis (aged 6 months to 18 years (mean age 7.4 years)) utilized either EpiCeram (n=59) or fluticasone propionate 0.05% cream (n=62), applied topically in comparable quantities to active areas twice daily for 28 days. All patients were instructed to use Cetaphil® lotion twice-daily on nonaffected areas. Assessments were made at baseline, day 14 and day 28.

The Primary clinical outcome was a reduction in disease severity as measured by changes in SCORAD scores (SCORing Atopic Dermatitis questionnaire). SCORAD values are determined by the percent of the patient's body effected by active dermatitis, the severity of the lesions (erythma, excoriation, edema, lichenification, oozing, and xerosis), and subjective scores of pruritus and insomnia.

Secondary outcomes were reduction in pruritus and improvement in sleep habits, rated on a subjective 10-point scale.

1. Sugarman et al. J. of Drugs in Derm. 2009:08:12 pg 1106-1111

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