The efficacy of amelxanox OraDisc^TM on the prevention of recurrent minor aphthous ulceration

Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: The OraDisc prevents ulcers from developing when compared with the vehicle patch.