Plasminogen - safe for treatment of chronic tympanic membrane perforation: a phase 1 randomized, placebo-controlled study

Abstract

Background There is a need for a simpler and accessible intervention to heal tympanic membrane perforations than myringoplasty that is todaýs golden standard. Experimental studies have identified plasminogen as a promising agent for medical treatment of chronic tympanic membrane perforation. Aims/Objectives This was a phase 1, prospective, randomized, placebo-controlled study with the main objective to evaluate the safety of injecting plasminogen in the vicinity of the tympanic membrane in subjects with chronic tympanic membrane perforation. Material and Methods Adults diagnosed with a dry chronic tympanic membrane perforation were recruited for an injection schedule with Human plasminogen 10. Adverse events, audiometry, VAS fluctuations and size of perforation, were monitored throughout the length of the study. Results It was possible to perform the injections according to schedule in all subjects. None of the subjects experienced any severe adverse events. Most common adverse event was ear pain. No signs of ototoxicity were reported. Conclusions and Significance This pilot study suggests that plasminogen injections close to the tympanic membrane as treatment for chronic tympanic membrane injections are safe and feasible, encouraging further dose-escalating studies.