A single-center prospective pilot open-label study to assess the efficacy of topical application of an oxygen-enriched oil for the treatment of angular cheilitis.

PURPOSE The aim of this pilot study was to clarify the acceptability and clinical efficacy of an oxygen-enriched oil-based gel for treatment of angular cheilitis. METHODS A class IIb medical preparation, packaged in appropriate syringes, was tested. Patients were instructed how to use the gel for 10 days: finger rub application (3 times daily) on the dried lesion after meals, without eating, drinking, or speaking for at least 30 min thereafter. The Wilcoxon signed-rank test was used to assess whether there were any differences in the distributions of reported pain and lesion dimension. A microbiological examination was also performed with oral swabs; chi-squared test was used to compare the difference in the presence of microorganisms before and after treatment. RESULTS Thirty patients were treated. A significant improvement in reported outcome and a significant reduction in the initially measured largest dimension of the lesion were observed after use of the clinical protocol. Additionally, a significant reduction in the pathogen count was found. CONCLUSION Even if with limitations, data showed that this medical preparation facilitated prompt recovery from reported pain, without adverse reactions. Further work with a larger study population, and possibly a randomized control medication, will be needed.