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.
BACKGROUND
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. 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.


METHODS
We 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.


RESULTS
Amlexanox 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.


CONCLUSIONS
Amlexanox 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.


BACKGROUND
Netherlands Trial Register NTR1727.
State Key Laboratory of Oral Diseases, West China College of Stomatology, Sichuan University, Sichuan, PR China. mengwenxia2006@163.com
Wenxia
W
Meng
Yi
Y
Dong
Jie
J
Liu
Zhi
Z
Wang
Xiaobo
X
Zhong
Ruiyang
R
Chen
Hongmei
H
Zhou
Mei
M
Lin
Lu
L
Jiang
Feng
F
Gao
Tao
T
Xu
Qianming
Q
Chen
Xin
X
Zeng
D000268:Adhesiveness; D000284:Administration, Oral; D000631:Aminopyridines / Q000008:administration & dosage*; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D002681:China; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D010147:Pain Measurement; D012008:Recurrence; D013281:Stomatitis, Aphthous / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D013607:Tablets; D016896:Treatment Outcome
D000631:Aminopyridines; D018926:Anti-Allergic Agents; D013607:Tablets; C045742:amlexanox