A clinical evaluation of 5% amlexanox oral paste in the treatment of minor recurrent aphthous ulcers and comparison with the placebo paste: a randomized, vehicle controlled, parallel, single center clinical trial

Abstract

Objectives: The primary objective of the following study is to determine and secondary objective is to compare the efficacy and safety of 5% amlexanox oral paste in the treatment of recurrent minor aphthous ulcers and also to evaluate the recurrence rate of aphthous ulcers over a period of 1 year.

Materials and methods: The present study was conducted on 100 patients diagnosed to have recurrent minor aphthous ulcers of which, 50 patients were advised to apply 5% amlexanox oral paste directly on the ulcer 4 times a day for 6 days and the other 50 patients were given placebo paste for the same duration. The baseline parameters were recorded on the first visit which includes ulcer size, pain, erythema and exudation. Efficacy and safety evaluations were made on the 4 th day and 6 th day. In total 30 patients with increased frequency of ulcers were advised to use 5% amlexanox paste for one whole year and the number of ulcers per month was recorded to evaluate any decrease in the recurrence rate.

Results: Male patients dominated the study with 73 males and 27 females. The mean age of the total sample was 26.6 years. The amlexanox group showed marked reduction in ulcer size (P < 0.001), significant reduction in the visual analog scale scores of pain (P < 0.001), significant lower scores of erythema and exudation (P < 0.001) when compared to the placebo group on the 6 th day of follow-up. The incidence of recurrence of ulcers was significantly reduced up to the 6 th month, but thereafter recurrence rate slowly increased.

Conclusions: Almost 5% of Amlexanox oral paste is clinically beneficial in reducing the pain, erythema, exudation and size of the ulcer over a period of 6 days. There was no definite conclusion drawn with respect to its effect on the recurrence rate of aphthous ulcers over a period of 1 year.