Ceragenix Pharmaceuticals, Inc., a biopharmaceutical company focused on infectious disease and dermatology, has received Institutional Review Board (IRB) approval to commence a multicenter study involving 90 children, aged 6 months to 18 years, with moderate-to-severe atopic dermatitis (eczema).
The study, which is expected to commence in July of this year and take place at private dermatology offices located in Santa Rosa, California and Trenton, New Jersey, will compare the use of EpiCeram, a non-steroidal skin barrier cream that received FDA marketing clearance in April 2006, to Cutivate, a commonly used mid-strength topical steroid that is approved for use in infants and children.
The objective of the clinical study is to determine whether EpiCeram, which does not contains steroids, can be as effective as a mid-strength steroid in alleviating the signs and symptoms of eczema in a paediatric patient population.
The outcome measurements of the study will include EASI, Scorard and Ossad scores, which are commonly used measures in determining disease improvement in atopic dermatitis studies. Both EpiCeram and Cutivate will be applied twice daily to the affected skin areas. The study will also measure trans-epidermal water loss (TEWL), which is an indicator of the skin barrier's integrity.
Over 15 million Americans suffer from eczema making it the most common childhood skin disorder. Patients and healthcare professionals have concerns over the long term use of topical steroids in the treatment of atopic dermatitis, as steroid use may lead to rebound flares and skin thinning.
"The market for prescription products used to treat eczema is close to $1 billion in the United States," stated Steven Porter, Chairman and CEO of Ceragenix "We are optimistic that this study will demonstrate at least comparable efficacy of EpiCeram to a mid-strength steroid, and thereby offer patients and their families an effective way to obtain symptomatic relief without the risks associated with topical steroid use. We are currently in active discussions with a number of pharmaceutical companies, as our intention is to partner EpiCeram with a firm that has strong capabilities in the commercialization of dermatological products."
Dermatology research has shown that children with atopic dermatitis (eczema) have dry, itchy skin due to excessive water loss, as their skin's barrier function is suboptimal. The lack of a fully effective skin barrier also allows external triggers, such as allergens and pollutants, to enter into the skin and cause an inflammatory reaction leading to the characteristic red scaly skin found in eczema sufferers.
EpiCeram, which is based on the research of Dr. Peter Elias, who serves as Ceragenix's Chief Scientific Officer, consists of a patented combination of lipids including those which are naturally found in the skin. The product is for external use only and is indicated to manage and relieve the burning and itching experienced with various types of dry skin conditions including atopic dermatitis, irritant contact dermatitis and radiation dermatitis. EpiCeram is contraindicated in patients with known hypersensitivity to any of the components of the formulation. For patients undergoing radiation therapy, EpiCeram may be applied as indicated by the treating Radiation Oncologist. The product does not contain a sunscreen and should not be used prior to extended exposure to the sun.
Ceragenix has licensed the lipid skin barrier technology from The Regents of the University of California on an exclusive basis for all prescription applications.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), more than 15 million people in the US have symptoms of atopic dermatitis. Children are more commonly affected than adults, with 90 per cent of acute dermatitis cases diagnosed by age five. Roughly 60 per cent of infants affected continue to have one or more symptoms of atopic dermatitis into adulthood.
NIAMS researchers project that US health insurance companies spend more than $1 billion per year on atopic dermatitis. Atopic dermatitis has also been found to affect patient quality of life due to its uncomfortable symptoms and how it alters physical appearance.