Fenig, E., Brenner, B., Katz, A., Sulkes, J., Lapidot, M., Schachter, J., … Gutman, H. (2001). Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. Oncology Reports, 8, 305–309.

To evaluate the use of Biafine or Lipiderm to prevent radiodermatitis.

Participants were randomized to one of three trial arms:  (a) Biafine, (b) Lipiderm, or the (c) control (no prophylactic treatment).

Study preparations were applied twice daily, staring 10 days prior to the beginning of radiation therapy (RT) and continuing until 10 days after treatment. Skin treatment was upgraded if necessary to steroids for grade 3 reaction antibiotics for grade 4 reactions or pause in therapy for grade 5 reactions.

• The sample was comprised of 74 women.
• Mean age was 69 years (range 42–85).
• Patients had T1-T2N0M0 breast cancer.
• Of the patients, 63% received concomitant tamoxifen.
• Patients with a complicated surgical wound or history of skin conditions were excluded.

Single site

The study was a randomized, controlled trial.

• The Radiation Therapy Oncology Group (RTOG) skin toxicity scale was used.
• Impressions were measured by an evaluation questionnaire using the same criteria. Relevant data were reported as a grade of reaction.
• Overall treatment success was determined by maximal treatment grade, total number of RT gaps needed, the patients’ weekly impressions, the radiotherapists' clinical impressions, and the study nurses’ impressions.
• Pearson correlation, chi-square, or Fisher exact tests were used to analyze the relationships between the three study arms.

• No objective data revealed an advantage in the Biafine or Lipiderm arms.
• Maximum skin treatment level was lower in the two intervention arms but was not significant.
• Patients in both intervention arms reported high levels of satisfaction (Biafine 86%, Lipiderm 85%).

The study neither refutes nor supports use of these products for existing reactions. These products did not show radioprotective effects.

• The study groups were too small to demonstrate any differences among study arms.
• Rubbing effects may have caused tissue damage.
• There were several responsible graders:  radiation therapist, nurses, and patients. Interrater reliability of the measurements was not addressed.