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 larg-est 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.