In this study, the rate of dermatitis healing was the objective criterion. The primary end point of the study was the speed of dermatitis healing. Dermatitis healing was defined as complete re-epithelialization of moist desquamation (dermatitis grades 2 and 3) areas. The healing rate of dermatitis (grades 2 and 3) was measured by comparing the rate of the decrease in the dermatitis area (cm/week) between the study and control arms. The mean dermatitis area Inhibitors,research,lifescience,medical (cm/week) was compared between the study and control arms
during 3 consecutive weeks of intervention. A ZSTK474 manufacturer minimum sample size required 24 patients in each arm to ensure 80% power at the 5% significance level for detecting a 40% improvement in the healing rate from 30% to 70%. The data were analyzed using statistical tests. The Chi-square test was employed to compare the data percentages at the beginning of the treatment such as age, radiotherapy dose, and stage of disease. The Mann Whitney test was used Inhibitors,research,lifescience,medical to compare the changes in the patients’ complaints such as pain and pruritus. And, the t Inhibitors,research,lifescience,medical test with Bonferroni correction was
used to compare burn area dermatitis by SPSS (version 17.0) and to compare the clinical measurements and the clinicopathological characteristics between the trial arms. A P value less than 0.05 was considered statistically significant. Results There was no meaningful difference in terms of baseline variables, including age, sex, dermatitis grade, total radiation dose, disease stage, and dermatitis area (cm2) between the two arms. The mean age of the control and study
arms was 47 (range=25-72) years and 49 (range=28-81) Inhibitors,research,lifescience,medical years, respectively. The mean radiation dose was 49.1 Gy (range=45-50.4 Gy) in the control arm and 48.8 Gy (range=45-50.4 Gy) in the study arm. The mean dermatitis area (summation of grades 2 and 3) was 13.54 (range=0.5-75.0) cm2 in the control arm and 17.02 (range=0.7-78.0) cm2 in the study arm (table 1). All the patients in both arms tolerated the topical treatments well, and no systemic or local reaction or dermatitis aggravation was observed. The analysis of data Inhibitors,research,lifescience,medical showed that 3 weeks’ use of topical Alpha ointment twice a day was more effective on also the healing of radiation-induced dermatitis than that of topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007); however, this difference was not significant for grade 2 dermatitis (P=0.343). This effect was also significant on the healing of grade 3 dermatitis (P=0.003) during 3 weeks of intervention (figure 2, table 2). Furthermore, the healing of both grade 2 and grade 3 dermatitis was significant in the second week of treatment (P=0.027 and P=0.004, respectively). Regarding the patients’ subjective complaints, although there was no statistically significant difference in burning sensation between the two arms over the 3-week intervention period (P=0.