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Ceragenix Announces Results from Phase IV Study of EpiCeram Meet,All Primary and Secondary Endpoints

sleep habits.

Study Results

Primary Outcome Measure (change in mean SCORAD score measured at Day 28 compared to Baseline).

Daily (twice) applications of both Cutivate(R) Cream and EpiCeram(TM) produced significant reductions in SCORAD scores at Day 28 compared to baseline values. Daily (twice) applications of EpiCeram(TM) produced statistically significant improvement of atopic dermatitis after 28 days with a reduction in SCORAD scores of 56.41% from baseline. Daily (twice) applications of the comparator product, Cutivate(R) cream, also produced statistically significant improvement of atopic dermatitis after 28 days with a reduction in SCORAD scores of 68.77%. Statistical comparison of the treatment effects (SCORAD scores) showed no statistically significant difference between treatment effects after 28 days of treatment.

Secondary Outcome Measures.

A. Percentage of subjects reaching clear or almost clear on IGA at Day 28

Assessment of the disease progression showed significant improvements in the IGA scores over time for both EpiCeram(TM) and Cutivate(R) cream with 61.1% of the EpiCeram(TM) patients assessed as clear or almost clear after 28 days of treatment and 76.2% of the Cutivate(R) cream patients being assessed as clear or almost clear at Day 28. Comparison of the disease progression results for both treatments showed no statistically significant difference between EpiCeram(TM) and Cutivate(R) cream after 28 days of treatment.

B. Assessment of Pruritus.

Patient reported assessments of pruritus also showed significant improvement from baseline after 28 days of treatment for both EpiCeram(TM) (3.54 change from baseline) and Cutivate(R) cream (3.75 change from baseline). No statistically significant differences were found between treatments after 28 days of treatment.

C. Assessment of Sleep Habits.

Patient reported assessments of sleep habits also showed significant improvement from b
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