The efficacy of amlexanox OraDisc on the prevention of recurrent minor aphthous ulceration.

The study was designed to determine the efficacy of OraDisc (active component 2 mg amlexanox) on the prevention of aphthous ulcers treated at the prodromal stage. Thermographic imaging was used to confirm the presence of a prodromal ulcer. Fifty-two patients were randomized to receive OraDisc (N = 26) or vehicle patches (N = 26). Patches were applied four times a day for 72 h over the prodromal area. The percentage of subjects who developed an ulcer at 72 h was compared between groups using the Fisher's exact test. About 50% of subjects in the OraDisc group developed an ulcer by day 4 compared with 69% in the vehicle group. Erythema score, ulcer size, pain scores and thermographically active area and temperature all showed trends towards healing in the OraDisc group. The OraDisc prevents ulcers from developing when compared with the vehicle patch.