The Phase II trial is designed to assess the safety, tolerability and efficacy of RTA 408 Lotion versus vehicle for the prevention and treatment of radiation dermatitis in breast cancer patients for whom radiation therapy (RT) is recommended.
Around 180 patients will be enrolled in the multi-center PRIMROSE trial and its primary efficacy endpoint is the time-averaged effect on radiation dermatitis severity.
Radiation dermatitis is a skin disease associated with prolonged exposure to ionizing radiation and it is experienced by a majority of patients receiving radiation therapy for cancer.
RT can damage the cellular structures in the skin and cause pain, ulceration, necrosis and fibrosis of exposed skin tissues.
At present, there are no approved agents for the prevention of radiation-induced dermatitis.
Reata chief medical officer Colin Meyer said: "Based on the preclinical and Phase 1 human data, we believe that RTA 408 Lotion may have the potential to become the first treatment to prevent and mitigate radiation dermatitis in breast cancer patients undergoing radiation therapy."