A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial

Wenxia Meng,Lu Jiang,Mei Lin,Hongmei Zhou,Tao Xu,Tao Xu,Xiaobo Zhong,Yi Dong,Zhi Wang,Feng Gao,Xin Zeng,Ruiyang Chen,Qianming Chen,Jie Liu

doi:10.1186/1745-6215-10-30

Abstract

BackgroundAmlexanox has been developed as a 5 percent topical oral paste for the treatment of patients with recurrent aphthous stomatitis (RAS) in most European countries. However, it is not yet available in China and has not been generally accepted in clinical treatment. The aim of this study was to explore the effectiveness of amlexanox oral adhesive pellicles in the treatment of minor recurrent aphthous ulcers, and compare the results with those of amlexanox oral adhesive tablets in order to analyse the difference between the two dosage forms of amlexanox.MethodsWe performed a randomized, blinded, placebo-controlled, parallel, multicenter clinical study. A total of 216 patients with minor recurrent aphthous ulcers (MiRAU) were recruited and randomized to amlexanox pellicles or placebo pellicles. Pellicles were consecutively applied four times per day, for five days. The size and pain level of ulcers were measured and recorded on treatment days 0, 4 and 6. Finally, the results were compared with those of our previous 104 cases treated with amlexanox tablets.ResultsAmlexanox oral adhesive pellicles significantly reduced ulcer size (P= 0.017 for day 4, P=0.038 for day 6) and alleviated ulcer pain (P=0.021 for day 4, P=0.036 for day 6). No significant difference was observed in the treatment effectiveness between the pellicle and tablet form of amlexanox.ConclusionsAmlexanox oral adhesive pellicles are as effective and safe as amlexanox oral adhesive tablets in the treatment of MiRAU for this Chinese cohort. However, pellicles seem to be more comfortable to use when compared with the dosage form of tablets. Therefore, in clinical practice, amlexanox oral adhesive pellicles may be a better choice for RAS patients.Trials registrationNederlands Trial Register NTR1727.

Highlights

Recurrent aphthous stomatitis (RAS) is one of the most common oral mucosa diseases
Minor Recurrent aphthous ulceration (MiRAU) is the most common form, which accounts for approximately 70% to 87% of the population with recurrent aphthous stomatitis (RAS) [1,2] and usually has 1 to 5 ulcers at one episode, with each ulcer varying from 3 to 10 mm [3]
In our previous clinical trial [11], we have demonstrated that amlexanox oral adhesive tablets are effective in the treatment of RAS without major side effects recorded, which were consistent with the previous trials [8,9]

Summary

Introduction

Recurrent aphthous stomatitis (RAS) is one of the most common oral mucosa diseases. It can affect both men and women of all ages, races and geographic regions. RAS represents a very common oral lesion, its etiology is unknown. Amlexanox has been developed as a 5 percent topical oral paste for the treatment of patients with recurrent aphthous stomatitis (RAS) in most European countries. It is not yet available in China and has not been generally accepted in clinical treatment. The aim of this study was to explore the effectiveness of amlexanox oral adhesive pellicles in the treatment of minor recurrent aphthous ulcers, and compare the results with those of amlexanox oral adhesive tablets in order to analyse the difference between the two dosage forms of amlexanox

Objectives

Methods

Results

Discussion

Conclusion