Fig 1.
Digital photographs of the measurement areas 1 (irradiated skin) and 2 (reference area on contralateral breast) under standardized lighting and with calibration of the images using a color reference card.
Table 1.
Patient characteristics and univariate comparison between treatment groups.
Fig 2.
Grading of acute skin toxicity according to CTCAE 4.03 by two radiation oncologists independently of each other exhibited significant inter-observer variability (p<0.001).
Fig 3.
Color measurements showed significant differences of the mean L*a*b* values (p<0.001) between irradiated skin (measurement area 1) and not irradiated control (measurement area 2).
Error bars show ± 1 standard deviation (SD).
Fig 4.
Skin treated with Bepanthen exhibited less redness than the skin treated with R1&R2 (a* = 11.4 ± 4.0 (SD) vs. 15.6 ± 4.9 (SD), p<0.001), but a drop in the yellow component (b* = 13.4 ±3.9 vs. 17.0 ± 4.5, p<0.001).
There was no difference in L* values between the treatments. Error bars show ± 1 standard deviation (SD).
Fig 5.
Comparison of CTCAE grade (according to radiation oncologist 1) and the mean SEV values.
Error bars show ± 1 standard deviation (SD). Mean difference between CTCAE grade 1 vs. 2 is SEV 205.6 (95%CI: 95.8–315.4; p<0.001), 1 vs. 3 is SEV 306.4 (95%CI: 76.4–536.4; p = 0.005) and 2 vs. 3 is 100.8 (95%CI: -124.7–326.3; p = 0.837).
Fig 6.
The new parameter ΔSEV showed less change in skin color with Bepanthen than with R1&R2 (p<0.001).
Error bars show ± 1 standard deviation (SD).