A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: Interim analysis

Maria Cristina Leonardi, Silvia Gariboldi, Giovanni Battista Ivaldi, Annamaria Ferrari, Flavia Serafini, Florence Didier, Luigi Mariani, Simona Castiglioni, Roberto Orecchia

Research output: Contribution to journalArticle

Abstract

Our aim was to assess the efficacy of MAS065D, a non-steroidal water-in-oil cream, in preventing and limiting skin reactions caused by radiation therapy (RT). 40 women treated with conservative breast cancer surgery followed by radiotherapy, were randomised to receive MAS065D (22 pts) or vehicle (18 pts). Radiotherapy was delivered in 20 fractions: 2.25 Gy to the whole breast plus a concomitant boost of 0.25 Gy to the tumour bed up to a total dose of 50 Gy. Evaluations of skin toxicity, erythema, and subjective symptoms were carried out weekly and 3 weeks after treatment completion. A statistically significant difference between vehicle and MAS065D groups was recorded regarding the maximum severity of skin toxicity (p <0.0001), burning within the radiation field (p = 0.039) and desquamation (p = 0.02), in favour of the latter. We conclude that MAS065D may be considered a safe and effective treatment in the prevention and minimization of skin reactions and associated symptoms.

Original languageEnglish
Pages (from-to)317-321
Number of pages5
JournalEuropean Journal of Dermatology
Volume18
Issue number3
DOIs
Publication statusPublished - May 2008

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Keywords

  • Breast
  • MAS065D
  • Radiation-induced dermatitis
  • Skin care

ASJC Scopus subject areas

  • Dermatology

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