Evaluation of Biafine Emulsion as a Prophylactic Agent for Radiation Dermatitis

Ahn, Sung Ja; Chung, Woong Ki; Nah, Byung Sik; Nam, Taek Keun; Park, Jin Gyoon

Abstract

This study was performed to determine if a topically applied Biafine emulsion is effective in reducing acute radiation dermatitis in patients receiving high dose radiation therapy. We limited the patients registration to curative or postoperative radiotherapy with full dose irradiation and the radiation portal area was the neck, upper back, chest wall, and perineum. Total 60 cases ( control 30 cases vs biafine 30 cases)were analyzed. The Biafine lotion was the product of the Laboratoire Medix S.A.(France) and the main effective composition that was known is the triethanolamine. Each patient's acute skin reaction was evaluated weekly from the initial treatment until the radiation therapy was completed. The skin was compared with respect to erythema, dry desquamation, moist desquamation, on-set time of symptoms, and intensity of the symptoms. Intensity of the symptoms was classified into the 6 grades. In the comparison of the subjective pruritis symptom, the incidence rate was 87%(26/30) in the control group vs 57%(17/30) in the Biafine group, respectively. The severity was greater and the on-set time was shorter in the control group than the Biafine group. In the comparison of the objective skin reaction, dry dermatitis in the control group occurred in 14 patients vs 8 patients in the Biafine group and the severity was also greater in the control group. The wet dermatitis incidence and severity were also lower in the Biafine group. The grade score of the skin reaction was higher in the control group than the Biafine group with the statistically significant difference(p=0.0005). The compliance of the Biafine emulsion was 100% and any skin change considering drug side effects was not appeared in all of the Biafine group patients. Through this clinical study, we knew that Biafine both attenuates and delays immediate skin reactions and Biafine has so far shown no detectable unpleasant or harmful side-effects.