Topical Biafine and Lipiderm for the prevention of radiation dermatitis: Arandomized prospective trial

We evaluated the effects of Biafine(TM) and Lipiderm(TM) ointments in preve nting radiation dermatitis. The study population included 74 patients after conservative surgery for early breast carcinoma who were referred for adju vant external beam irradiation. Patients were randomized to receive Biafine or Lipiderm or no treatment. Both study preparations were applied twice da ily, starting 10 days before onset of radiotherapy and continuing until 10 days after its completion. The skin treatment was upgraded, if clinically n ecessary, to steroids (grade 3), antibiotics (grade 4), or pause in therapy (grade 5). Success of treatment was evaluated according to the maximal lev el of skin treatment, the number of gaps in radiation therapy, the impressi on of the patients and the subjective skin reaction, and scores of the stud y nurse and radiotherapist. The three groups were comparable for all clinic al features, except for a lower mean age of the Biafine group. Comparative analysis of the results showed no advantage for either preparation compared to the control arm other than maximal treatment level required for a skin reaction (mean 1.7 and 1.6 vs. 2.2), which did not reach statistical signif icance (p=0.145). Nevertheless, 86% of the patients in both the Biafine and Lipiderm arms expressed satisfaction with the respective ointments. In con clusion, neither Biafine nor Lipiderm seems to have a radioprotective effec t.