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.

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.
Authors	Maria Cristina Leonardi, Silvia Gariboldi, Giovanni Battista Ivaldi, Annamaria Ferrari, Flavia Serafini, Florence Didier, Luigi Mariani, Simona Castiglioni, Roberto Orecchia
Journal	European journal of dermatology : EJD (Eur J Dermatol) 2008 May-Jun Vol. 18 Issue 3 Pg. 317-21 ISSN: 1167-1122 [Print] France
PMID	18474463 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	Dermatologic Agents Drug Combinations Oleic Acids Plant Extracts Plant Oils Thiazolidines enoxolone, hyaluronic acid, levomenol, telmesteine, vitis vinifera drug combination shea oleine telmesteine Hyaluronic Acid Glycyrrhetinic Acid
Topics	Administration, Cutaneous Adult Aged Breast Neoplasms (radiotherapy) Dermatitis (etiology, prevention & control) Dermatologic Agents (administration & dosage, chemistry) Double-Blind Method Drug Combinations Female Glycyrrhetinic Acid (administration & dosage) Humans Hyaluronic Acid (administration & dosage) Middle Aged Oleic Acids (administration & dosage) Pain (etiology, prevention & control) Plant Extracts (administration & dosage) Plant Oils (administration & dosage) Pruritus (etiology, prevention & control) Radiation Injuries (drug therapy, prevention & control) Radiotherapy (adverse effects) Radiotherapy Dosage Severity of Illness Index Skin (radiation effects) Statistics, Nonparametric Thiazolidines (administration & dosage) Treatment Outcome Vitis

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