Ceragenix gets IRB OK for eczema trial in children

The USA's Ceragenix Pharmaceuticals has received Institutional Review Board approval to commence a multicenter study involving 90 children, aged six months to 18 years, with moderate-to-severe atopic dermatitis (eczema).

The study, which is expected to commence in July, will compare the firm's non-steroidal skin barrier cream EpiCeram, which received US marketing clearance in April, to Pharmaderm's Cutivate (fluticasone), a commonly-used mid-strength topical steroid approved for use in infants and children. This will aim to determine whether EpiCeram can be as effective as a mid-strength steroid in alleviating the signs and symptoms of eczema in pediatric patients.

Denver, Colorado-based Cerganix noted that over 15 million Americans suffer from the condition, making it the most common childhood skin disorder. However, both patients and health care professionals have concerns over the long-term use of topical steroids as they may lead to rebound flares and skin thinning.