ONCOLOGY REPORTS 8: 305-309, 2001 Topical Biafine and Lipiderm for the prevention of radiation dermatitis: A randomized prospective trial EYALFENIG 1 , B ARUCH BRENNER 1 , ALANKATZ 1 , JAQUELINE SULKES 2 , MOSHE LAPIDOT 3 , JACOB SCHACHTER 1 , HANA MALIK 1 , AARON SULKES 1 and HAIM GUTMAN 4 'institute of Oncology, Epidemiology Unit, Departments of Dermatology, and Surgery B, Rabin Medical Center, Beilinson Campus, Petah Tiqva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Received May 30, 2000; Accepted October 5, 2000 zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLK Abstract. We evaluated the effects of Biafine™ and Lipiderm™ ointments in preventing radiation dermatitis. The study population included 74 patients after conservative surgery for early breast carcinoma who were referred for adjuvant external beam irradiation. Patients were randomized to receive Biafine or Lipiderm or no treatment. Both study preparations were applied twice daily, starting 10 days before onset of radiotherapy and continuing until 10 days after its completion. The skin treatment was upgraded, if clinically necessary, to steroids (grade 3), antibiotics (grade 4), or pause in therapy (grade 5). Success of treatment was evaluated according to the maximal level of skin treatment, the number of gaps in radiation therapy, the impression of the patients and the subjective skin reaction, and scores of the study nurse and radiotherapist. The three groups were comparable for all clinical 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 significance (p=0.145). Nevertheless, 86% of the patients in both the Biafine and Lipiderm arms expressed satisfaction with the respective ointments. In conclusion, neither Biafine nor Lipiderm seems to have a radioprotective effect. Introduction External beam radiation therapy invariably involves skin irradiation and can induce adverse skin responses. The mechanism of this action and methods of minimizing its effect have been the focus of many investigations (1). zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Correspondence to: Dr Haim Gutman, Department of Surgery B, Rabin Medical Center, Beilinson Campus, Petah Tiqva 49 100, Israel E-mail: hgutman@clalit.org.il Key words: Biafine, Lipiderm, radiation dermatitis, radioprotection Adverse skin responses are manifested clinically by dry erythema, and at higher doses, by moist desquamation and destruction of the skin adnexa (hair, sebaceous and sweat glands) (2). Apart from patient's discomfort, the dermal toxicity may limit the total radiation dose and cause unplanned gaps in the treatment program. A wide variety of creams and ointments, such as moisturizing formulas, aloe vera gel, anti-inflammatory and antihistamine compounds, and steroid and antibiotic preparations, are currently in clinical use. None has been prospectively proven to reduce the rate or severity of radiation dermatitis when used prophylactically. Biafine™ (Genmedix Ltd., France), an oil-in-water emulsion with non-steroidal anti-inflammatory properties, was introduced into clinical practice almost 30 years ago and remains in widespread use today. Preclinical trials have demonstrated profound effects of Biafine on the dermal concentrations of various immunomodulators, such as interleukins 1 and 6. These cytokines, among others, are believed to play an important role in the initiation and propagation of the dermal radiation reaction. However, no formal study of the radioprotective role of Biafine has been conducted. Lipiderm™ (G-Pharm Ltd., France), a moisturizing cream commonly used by cosmeticians in Europe and in Israel, has recently been introduced for use in radiotherapy. The clinical benefit of Lipiderm is believed to derive from both the hydrating effect of its fatty ingredients (3) and the anti- inflammatory effect of one of its active components, a bisabolol (4). It was the authors' clinical impression, supported by other colleagues, that there is some basis for the radioprotective properties attributed to this product. In the present study we describe the results of a randomized prospective trial evaluating the effectiveness of Biafine and Lipiderm in preventing radiation dermatitis. Materials and methods Patients. The study population included 75 consecutive patients after conservative surgery for early breast carcinoma (T1-T2N0M0) who were referred for adjuvant external beam radiation. Diagnosis and staging were confirmed in all cases. Patients with a complicated surgical wound, history of skin or collagen disease, and prior or concomitant chemotherapy