RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation
therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to
its direct physical complications and the resulting impact on overall quality of life, it can
also be a dose-limiting toxicity requiring changes to the prescribed course of radiation
therapy. The most common strategy employed in an attempt to prevent or minimize radiation
dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the
area clean, and minimizing exposure to potential mechanical irritants, such as scratching and
rough clothing. However, this strategy has been shown to lack clinically significant
efficacy. Consequently, there is a clinical need for new treatments that are effective in
protecting against radiotherapy-induced oxidative stress and the subsequent development of
radiation dermatitis.
Based on data from previous studies in animals and humans, Reata believes that omaveloxolone
(RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology
patients undergoing radiation therapy.
This randomized, double-blind, vehicle-controlled, parallel-group trial will study the
efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3%
and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is
recommended.