A double-blind, vehicle-controlled clinical study to evaluate the efficacy of MAS065D (XClair), a hyaluronic acid-based formulation, in the management of radiation-induced dermatitis

Abstract

This study was designed to assess the efficacy and tolerability of MAS065D (Xclair) compared to a vehicle control in the management of radiation dermatitis in patients receiving radiotherapy for breast cancer. Twenty patients were randomized blindly to use the two study substances, three times daily, on separate sections of irradiated skin throughout the duration of radiotherapy and for two weeks afterwards. Patients were monitored before therapy, weekly during therapy, and for 2 weeks after radiotherapy was completed. Skin appearance according to National Cancer Institute (NCI) toxicity criteria, erythema rating, transepidermal water loss (TEWL), skin hydration, patients' view of itch, pain, acceptance, and view of each cream and adverse events, were monitored; at the final visit patients and investigators expressed their preference for one of the creams. MAS065D showed statistically significant superiority in the outcomes of NCI grading for radiation dermatitis and erythema. Patients' and investigators' preferences for one of the study substances were statistically in favor of MAS065D. Very few patients recorded nonzero itch and pain scales, so no significant differences emerged between the two groups. It was concluded that MAS065D can provide an effective option for managing radiation dermatitis although further studies are needed to assess its effect on pain and itch.