Abstract
A comparative clinical trial of TL-102M (adhesive powder preparation containing beclomethasone dipropionate) and Kenalog in patients with erosive or ulcerating stomatitis was performed cooperatively in 7 institutions.
The results could be summarized as follows:
1. The degree of overall improvement more than ‘effective’ was 80.6% in TL-102M treated group and 51.9% in Kenalog treated group, providing a significant difference in favor of TL-102M (P<0.05, X2-test).
2. No adverse reactions were noted in either the TL-102M or Kenalog groups.
3. The rate of overall impression more than ‘good’ by patient was 93.3% in TL-102 group and 70.4% in Kenalog group, indicating a favorable patient's impression in TL-102M group (P<0.10, X2-test).
4. The degree of usefulness more than ‘useful’ was 90.3% in TL-102M group and 63.0% in Kenalog group. A significantly superior result was obtaned in TL-102M group (P<0.05, X2-test).
From these results mentioned above, TL-102M was concluded to be effective, highly safe, and useful drug for treating stomatitis accompanying erosion or ulcer.
