Primavera, G., Carrera, M., Berardesca, E., Pinnaró, P., Messina, M., & Arcangeli, G. (2006). 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. Cutaneous and Ocular Toxicology, 25, 165–171.

To assess the efficacy and tolerability of MAS065D (Xclair™) compared to a vehicle control in the management of radiation dermatitis

There was a washout period of seven days for other topical medication prior to the beginning of treatment. The treatment field was divided into two sections. Participants were randomized into two groups. One received MASO65D on section one and the control vehicle on section two. The other participant group received the reverse. Participants were to apply the product three times a day upon the start of treatment and continue for two weeks after the completion of treatment.

• N = 22 patients
• MEDIAN AGE = 57 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Total dose of 50–70 Gy over four to six weeks in daily fractions, no concurrent chemotherapy

• LOCATION: Radiation facility in Italy

• Double-blind, vehicle-controlled longitudinal study
  • Quasi-experimental design with patients as their own controls

• National Cancer Institute (NCI) toxicity scale 0–4 used to grade skin toxicity
• Transepidermal water loss (TEWL) was measured with a Tewameter^®
• Erythema rating measured using the Mexameter^® MX 16
• Skin hydration measured using the Corneometer^® CM 825
• Visual numeric scale (1–10) to measure pain and itch
• Wilcoxon matched-pairs signed-rank test for skin grading and other measurements

Overall toxicity scale results across groups were

• Grade 1: 35%
• Grade 2: 35%
• Grade 3: 5%
• Grade 4: 0%

The mean scores for NCI grading in both treatment groups increased from visit 1 to visit 6 and then declined. With MASO65D, the mean NCI scores were lower in five of the assessment weeks; however, this difference was statistically significant only at week 4. The mean score for erythema with MAS065D was found to be significantly lower than that of the control (p = 0.031) only at visit 5. The mean score for TEWL/hydration observed in the breast sections treated with MAS065D was lower than in those treated with the control vehicle from visit 3 onward, but this was not statically significant Both the patients and investigators preferred the MAS065D (p = 0.007 and p = 0.035, respectively). The pain and itch scores were mainly 0 throughout the study, and there was no difference noted. No adverse events were reported with either skin product.

MAS065D is effective in the management of radiation dermatitis, but further studies are necessary.

• Small sample size
• Total dose was 20–70 Gy (mean ± SD: 65.5 ± 13.9) over one to six weeks (5.6 ± 1.4). At the low end of dosage and short duration of treatment, skin toxicity would be expected to be lower. This factor was not discussed in the study. The authors did not describe TEWL, erythema, or skin hydration measurement sufficiently, or the manner in which the instruments provided these measures.
• The way in which patient and investigator preference were measured was not clearly identified.