Topical Ectoin Versus Topical Dexpanthenol for Managing Acute Radiodermatitis Associated With Breast Cancer Radiotherapy: A Randomized Double-Blind Study.

Background: Radiodermatitis is a common side effect of breast cancer radiotherapy; however, there is no current consensus regarding an effective standard therapy. Objective: To evaluate the efficacy of topical ectoin versus dexpanthenol in the management of acute radiodermatitis after breast cancer radiotherapy. Methods: Fifty patients randomly used dexpanthenol 5% cream (25 patients), or ectoin 7% cream (25 patients), applied twice daily to the irradiated area during and for 2 weeks after radiotherapy. The study was stratified by the radiotherapy schedule and was double-blind. Radiodermatitis grade, radiation-associated symptoms, and adverse events were assessed weekly during radiotherapy and 2 weeks thereafter. Skin-related quality of life (QOL) scores were measured using the Skindex-16 questionnaire. Results: Both agents were effective in preventing severe radiodermatitis (≥G3). Ectoin had a lower radiodermatitis grade level than dexpanthenol, with a significant difference at week 2 (P = 0.008). Radiation-associated pain (P = 0.003) and itching (P = 0.001) were lower with ectoin than dexpanthenol. Side effects were not significantly different between the 2 treatments (P = 0.107). Ectoin showed less QOL impairment than dexpanthenol. The radiation schedule was an independent predictor for radiodermatitis persistence. Conclusion: Ectoin showed some clinical benefit over dexpanthenol in improving radiation dermatitis and the radiation schedule is a predictor of radiodermatitis persistence.