Comparing the Efficacy of Dermolina-Henna Cream with Mometasone Cream in Improving Radiodermatitis Amongst Patients with Breast Cancer: A Randomized Active-control Double-blind Clinical Trial

Purpose: Acute radiodermatitis is one of radiotherapy most common complications. Despite the high prevalence of radiodermatitis, few studies investigated how to prevent or treat this complication. Hence, any standard treatment has not been introduced so far. We sought to evaluate the efficacy of Dermolina-Henna cream, a new polyherbal formulation, compared to Mometasone cream for alleviating radiodermatitis amongst breast cancer patients. Methods: Women over 18 years of age with breast cancer undergoing radiotherapy were included in this double-blind active-control randomized clinical trial. A total of 93 eligible patients was randomly divided into the Dermolina-Henna and Mometasone groups. Patients were instructed to apply a thin layer of each cream once daily on their lesions at least 3 hours after radiotherapy for 4 weeks, and if grade I or II radiodermatitis developed, also afterward. Patients were visited weekly until end of study at after 4 weeks. RTOG (Radiation Therapy Oncology Group) standard questionnaires were evaluated and recorded every week as the primary outcome.Results: The trends on decrease in number of lesions, erythema, radiodermatitis grade, burning sensation, pain, and itchiness were statistically significant for each treatment, separately (P<0.001), except for radiodermatitis grade in Mometasone group (P=0.4). Dermolina-Henna was significantly better than Mometasone in alleviating burning sensation (P<0.001) and itchiness (P=0.041).Conclusion: In summary, we showed that Dermolina-Henna cream and Mometasone cream were significantly effective in decreasing severity of radiodermatitis symptoms amongst patients with breast cancer. Dermolina-Henna cream was significantly superior to Mometasone cream in alleviating burning and itchiness. IRCT20200115046144N1, 2020-03-04, retrospectively registered.