Randomized double-blind trial of prophylactic topical Evozac(®) Calming Skin Spray for gefitinib-associated acne-like eruption

BACKGROUND: “Gefitinib” is a first-generation epidermal growth factor receptor tyrosine-kinase inhibitor. More than half of patients receiving gefitinib develop acne-like eruption. Evozac(®) Calming Skin Spray (Evaux Laboratoires, Évaux-les-Bains, France) is made of Évaux thermal spring water and commonly used for the treatment of dermatological toxicities caused by anti-epidermal growth factor receptor therapy. The aim of the study reported here was to test the effect of Evozac Calming Skin Spray on the prevention of rash in patients receiving gefitinib. METHODS: Non-small-cell lung cancer patients preparing to initiate gefitinib therapy were randomly assigned to apply Evozac Calming Skin Spray or physiological saline to the face three times a day. The treatment was started on the same day as initiation of gefitinib therapy and continued for 4 weeks. RESULTS: A total of 51 patients in the Evozac Calming Skin Spray group and 50 patients in the physiological saline group completed the study per the protocol. The number of facial lesions peaked at the end of 3 weeks in both groups. There were significantly fewer lesions in the Evozac Calming Skin Spray group than in the physiological saline group at the end of 1 week (0.25 versus [vs] 1.10, P=0.031) and 3 weeks (6.67 vs 12.26, P=0.022). Patients from the Evozac Calming Skin Spray group also developed fewer facial lesions at the end of 2 weeks and 4 weeks, however, the difference was not statistically significant. At the end of 4 weeks, fewer patients from the Evozac Calming Skin Spray group developed rash of grade 2 or greater severity (17.6% vs 36.0%, P=0.037), or experienced rash-associated symptoms (13.7% vs 34.0%, P=0.017). CONCLUSION: Prophylactic treatment with Evozac Calming Skin Spray appears to decrease the number of facial lesions at the peak of the rash, reduce the incidence of grade 2 or more severe rash and relieve rash-associated symptoms.