Efficacy of a Mucoadhesive Patch Compared with an Oral Solution for Treatment of Aphthous Stomatitis

Shemer, Avner
Amichai, Boaz
Trau, Henri
Nathansohn, Nir
Mizrahi, Boaz
Domb, Abraham J

¹ Department of Dermatology, C. Sheba Medical Center, Ramat-Gan, Israel
² Huzot Clinic, Clalit Health Services, Ashkelon, Israel
³ Department of Medicinal Chemistry and Natural Products, School of Pharmacy, Faculty of Medicine, The Hebrew University, Jerusalem, Israel

Correspondence: Prof. Abraham J. Domb, Department of Medicinal Chemistry and Natural Products, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, 91120, Israel. E-mail: [email protected]

Drugs in R & D 9(1):p 29-35, January 1, 2008.

Objective

The purpose of this study was to evaluate the efficacy and tolerability of a mucoadhesive patch compared with a pain-relieving oral solution for the treatment of aphthous stomatitis.

Methods

Patients with active aphthous stomatitis were randomly treated either once a day with a mucoadhesive patch containing citrus oil and magnesium salts (n = 26) or three times a day with an oral solution containing benzocaine and compound benzoin tincture (n = 22). All patients were instructed to apply the medication until pain had resolved, and completed a questionnaire detailing multiple clinical parameters followed by an evaluation of the treatment.

Results

The mucoadhesive patch was found to be more effective than the oral solution in terms of healing time (mean ± SD: 36.0 ± 22.8 hours vs 134.7 ± 57.7, p < 0.001) and pain intensity after 12 and 24 hours (3.7 ± 2.8 vs 6.3 ± 2.6, p = 0.003, and 2.3 ± 2.7 vs 5.7 ± 2.5, p < 0.001, respectively). Local adverse effects 1 hour after treatment were significantly (p < 0.01) less frequent among the mucoadhesive patch patients compared with the oral solution patients.

Conclusions

The mucoadhesive patch was found to be significantly more effective and better tolerated than the oral solution in the treatment of aphthous stomatitis.