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Further evaluation of Debacterol® for the treatment of recurrent aphthous stomatitis. N.L. Rhodus, J. Bereuter (University of Minnesota, Minneapolis, MN)Recurrent aphthous stomatitis (RAS) is a very common condition. Current treatment for RAS includes anti-inflammatory and other agents which palliate the symptoms. The purpose of this continuing clinical trial was to further compare a topical agent used for RAS treatment, Debacterol (D) vs. Kenalog -in-Orabase (KO) as previously reported by the laboratory ( JDR 1997;abstr.#3487) in a larger subject population of 40 individuals (n=20;14-F;6-M; mean age 37.3 yrs. in each arm). After the diagnosis of RAS, clinical examinations were performed as well as a subjective evaluation of symptoms for each subject. The subjects did not use any other medications. Both agents were applied topically (the frequency varied depending with the arm of subjects) in specified intervals. Ulcer size and erythema measurements as well as subjective (100mm VAS) evaluations of pain were made at Day 0, 3, 6, and 10. The results indicated that 100% of the ulcers clinically healed and caused no pain in both groups by Day 10. A significant decrease in the VAS in the D group at 3 days indicated a significant improvement in pain ( > 70% reduction ) compared to the KO group. After day 6, 70% of the ulcers had clinically disappeared with no symptoms in the D group as compared to 30% in the KO group. In some individuals in the K group, there was a decrease in the clinical measures over the D group, but the VAS revealed no significant change. These results indicate significant relief of symptoms accompanying RAS with the application of Debacterol® which may or may not correspond to clinical improvement.
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