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Earwax and topic alpha-tocopherol acetate: The cerumenolytic action.

Domenico Testa*, Anna Donadio, Michele Andreotti, Giuseppe Massaro, Giovanni Motta

Objective: Cerumen (ear wax) is a physiologic secretion of ceruminous and sebaceous glands of the external ear canal. Its main function is lubricate the external auditory canal, creating a humid and warm environment. Cerumen usually, is expelled outside the ear canal to the movements of the jaw. Sometimes, however, in some people due to the shape of the ear canal or due to inappropriate cleaning maneuvers, ear wax can accumulate, causing an obstruction (plug). When treatment is indicated, there are three recommended ear wax removal methods: irrigation, manual removal, cerumenolytic agents.

Methods: For the study 137 patients were enrolled, age range 6-80 years old, mean 46.7, the subjects are divided in three groups standing the age and created a score in relation to the ear wax plug (0: Complete obstruction of external auditory canal; 1: Ear wax plug obstructing 2/3 of external auditory canal; 2: Ear wax plug obstructing 1/3 of external auditory canal; 3: Absence of ear wax). Each patient underwent topic treatment with alpha tocopherol acetate and polydecene (Filme Oto Spray), 3 puffs each external auditory canal, 3 times/day for 7/14 days. The aim of the treatment was to completely remove the ear wax plug in 7 days (primary endpoint) or in 14 days (secondary endpoint).

Results: Children and adolescent patients reached endpoints more than adults and older patients, with statistical significance (p<0.05).

Conclusion: The use of the composition of alpha-tocopherol acetate (vitamin E) and polydecene (Filme Oto Spray) allows to cleaning of the auditory canal and the complete visualization of the tympanic membrane, 7 days after the first application.