An evaluation on the efficacy and safety of amlexanox oral adhesive tablets in the treatment of recurrent minor aphthous ulceration in a Chinese cohort: a randomized, double-blind, vehicle-controlled, unparallel multicenter clinical trial

Objective. The objectives of this study were to clinically determine the topical efficacy and safety of amlexanox oral adhesive tablets in the treatment of recurrent minor aphthous ulcerations (MiRAU) in a Chinese cohort. Study design. A randomized, double-blind, vehicle-controlled, unparallel multicenter clinical trial was carried out. The tablets were applied by subjects themselves 4 times a day for 5 days. Four parameters (pain scale, size change, degree of erythema and exudation, and efficacy index) were recorded both before (baseline) and during the trial (on the morning of days 4 and 6). Results. There were 104 and 108 subjects who fulfilled the trial in the amlexanox group and the vehicle-control group, respectively. Group differences for all parameters but degree of erythema and exudation of day 4 were statistically significant both for the day 4 visit and the day 6 visit (P < .05). No systemic side effects were reported. Conclusions. Amlexanox oral adhesive tablets are effective and safe in reducing aphthous ulcer pain and lesion size, as well as erythema and exudation in this Chinese cohort.