Winston-Salem, N.C., March 21, 2018 – KeraNetics announces today that the next product in its KeraStat® wound dressing portfolio, KeraStat® Cream, has begun pilot human clinical trial testing. The randomized open-label study is designed to evaluate the feasibility of the use of KeraStat Cream in women undergoing radiation therapy for breast cancer who may develop a skin condition called radiation dermatitis. The study will also look at safety, tolerability, and effectiveness of the cream in comparison to the current standard of care. The study will take place at Wake Forest Baptist Health and is being conducted under an Institutional Review Board (IRB) approved protocol.
The initial work that led to the development of the KeraStat product line for cutaneous radiation injuries was funded under a Biomedical Advanced Research and Development Authority (BARDA) contract HHSO100201200007C. Radiation dermatitis, a cutaneous radiation injury, is seen in 85% of patients undergoing radiation therapy to the head, neck, breast, chest wall, perineum, or vulva; negatively affects patients’ quality of life; and can cause treatment interruptions. “We are excited to begin this work that may, in a small way, help improve the lives of patients struggling with cancer treatments” said Dr. Luke Burnett, the Chief Science Officer at KeraNetics.
Unfortunately, radiation exposure is a real threat in today’s world. In addition to radiation dermatitis, preclinical testing suggests that KeraStat Cream may be an appropriate medical countermeasure for cutaneous radiation injury. The product is designed to be easily transportable and requires no healthcare training to apply. Dr. Burnett added that “we hope that this pilot study is the first step in finding both an evidence-based solution to radiation dermatitis and an easily deployed medical countermeasure that can address the issues of a national radiation emergency.”