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 sample was comprised of female, Caucasian patients with breast cancer.
• Mean age was 57.26 years, with a range of 33.1 to 76.9 years.
• All patients scored 100% on the Karnofsky Scale.

The study took place at the European Institute of Oncology in Milan, Italy.

The study used a randomized double-blind vehicle-controlled design.

• Skin toxicity was graded using the National Cancer Institute Common Termonology Criteria for Adverse Events for erythema, desquamation, edema, moist desquamation and ulceration.
• Differences between arms of study were analyzed using the Mann-Whitney Test.
• Itch, pain, and burning were assessed using a 0–10 cm visual analogue scale, with zero being \"none\" and 10 being \"worst severity possible.
• The Karnofsky performance score, tobacco use, breast size, breast condition, and skin pigment were recorded at baseline.

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.

• The study sample size was small.
• A higher proportion of women with fair skin was allocated to the vehicle group, which has the potential to confounded findings.
• Although five patients were withdrawn from the study, results are stated for 40 patients. It is not clear if the five cases withdrawn were eliminated from the statistical analysis.
• Researchers state that results for severity of symptoms, measured with the visal analogue scale, were analyzed with Chi-square analysis or Mann-Whitney, which are not the most appropriate for integer scale data.