Leonardi, M.C., Gariboldi, S., Ivaldi, G.B., Ferrari, A., Serafini, F., Didier, F., . . . Orecchia, R. (2008). A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: Interim analysis. European Journal of Dermatology, 18, 317–321.
To assess the efficacy of MASO65D (Xclair™) in managing radiation dermatitis (RD) during radiation therapy and the follow-up period
Patients were randomized to use of MASO65D or the control cream. The control vehicle was an emollient-based cream that was similar in color and consistency but did not contain key ingredients. Patients had to observe a washout period of seven days. Patients were also instructed to apply study cream on the irradiated area three times daily, starting on first day of irradiation and continuing until three weeks after completion of radiation therapy. Patients were examined at weekly intervals during radiation therapy and three weeks after its completion.
The study took place at the European Institute of Oncology in Milan, Italy.
The study used a randomized double-blind vehicle-controlled design.
The study demonstrated a statistically significant difference between vehicle and MAS065D groups regarding the maximum severity of skin toxicity (p < 0.0001), symptoms of burning within the radiation field (p = 0.039), and desquamation (p = 0.02). In the MAS065D group, 13.5% reported mild-to-moderate desquamation, compared with 50% in the vehicle group. A higher proportion of the experimental group had no desquamation. The most significant differences between the two groups were recorded after three weeks of treatment. Both study creams were well tolerated for their cosmetic acceptability. No adverse events were observed or reported in either group of patients who completed the study.
MAS065D had a significantly better outcome with prevention and treatment of skin reactions.