The efficacy of amlexanox OraDisc 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.

• Authors: B Murray, P A Biagioni, P-J Lamey
• Journal: Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology (J Oral Pathol Med) Vol. 35 Issue 2 Pg. 117-22 (Feb 2006) ISSN: 0904-2512 [Print] Denmark
• PMID: 16430743 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aminopyridines
• Anti-Allergic Agents
• Placebos
• amlexanox

Topics

• Administration, Topical
• Adult
• Aminopyridines (administration & dosage, adverse effects, therapeutic use)
• Anti-Allergic Agents (administration & dosage, adverse effects, therapeutic use)
• Body Temperature (drug effects)
• Double-Blind Method
• Erythema (prevention & control)
• Female
• Humans
• Male
• Mouth Mucosa (drug effects)
• Pain (prevention & control)
• Placebos
• Recurrence
• Safety
• Stomatitis, Aphthous (prevention & control)
• Thermography
• Time Factors
• Treatment Outcome
• Wound Healing (drug effects)