The efficacy and safety of 50 mg penicillin G potassium troches for recurrent aphthous ulcers.
OBJECTIVE
To determine both the efficacy and safety of the topical application of 50 mg penicillin G potassium troches (Cankercillin) in the treatment of minor recurrent aphthous stomatitis (RAS).


METHODS
The investigation used a phase 2 double-blind, randomized placebo-controlled trial with a no-treatment arm. Subjects with minor aphthous ulcers of duration <48 hours were followed for 1 week. The primary endpoint for efficacy was time (days) to complete ulcer resolution, and the secondary endpoint was time (days) to complete pain relief.


RESULTS
Thirty-one, 33, and 36 subjects were randomized to the active treatment, placebo, and no-treatment arms, respectively. Baseline findings were heterogeneous across arms. Subjects who received penicillin G treatment had complete ulcer healing and pain relief significantly earlier than those in the placebo and no-treatment arms. No allergic reactions were observed.


CONCLUSIONS
Topical penicillin G, by mechanisms which remain unclear, reduces the time of healing and pain relief of minor aphthous ulcers with minimal safety concerns. Larger phase 3 studies are necessary to confirm these findings.
Kerr
A Ross
AR
Bluestone Center for Clinical Research, New York University, New York, USA. ark3@nyu.edu
Drexel
Catherine A
CA
Spielman
Andrew I
AI
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010400:Penicillin G / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D016016:Proportional Hazards Models; D012008:Recurrence; D012449:Safety; D013281:Stomatitis, Aphthous / Q000188:drug therapy* / Q000517:prevention & control; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
D000900:Anti-Bacterial Agents; D010919:Placebos; D010400:Penicillin G