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

c dermatitis is a chronic childhood skin condition that may affect patients for many years. Dermatology agents currently used to treat atopic dermatitis and other inflammatory skin disorders have important limitations and two commonly used immunosuppressants have been the subject of a controversial FDA imposed "black box" warning of a potential link between long term use and certain cancer risks. The use of EpiCeram(TM) does not raise any of the major safety concerns associated with the use of topical steroids and immunosuppressants.

Steve Porter, Ceragenix's Chairman and CEO stated, "We are very pleased with these results. We have just demonstrated that EpiCeram(TM) is comparable to a mid strength steroid in treating the symptoms of atopic dermatitis after a 28 day treatment regimen. We believe that EpiCeram has the potential to become the foundation of a new and improved paradigm in the treatment of this common childhood skin disorder which affects over 15 million Americans."

Study Design

The study was an investigator-blinded, randomized controlled study conducted at five centers which evaluated a total of 113 patients in two groups of children (ages 6 months to 18 years) with moderate-to-severe atopic dermatitis treated with either Cutivate(R) Cream, a mid-potency topical steroid, or EpiCeram(TM). The study was primarily conducted during the winter months of December ('06), January ('07) and February ('07).

Primary and Secondary Outcome Measures.

According to the protocol, the primary outcome measure was the change in mean SCORAD score measured at Day 28 as compared to the baseline. The protocol's secondary efficacy parameters were: -0-

       a) Percentage of subjects reaching clear or almost clear on

          Investigator's Global Assessment (IGA) at Day 28;

       b) Change in patient reported assessments of pruritus (itch);

          and

       c) Change in patient reported assessment of disturbance of

      
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