Treatment of recurrent aphthous stomatitis with clofazimine

Objective The aim was to investigate the safety and efficacy of clofazimine for the treatment of recurrent aphthous stomatitis. Study design In this randomized controlled partially blind study, 23 patients received clofazimine 100 mg daily for 30 days and then 100 mg every other day. Twenty-three patients received colchicine 0.5 mg 3 times daily. Twenty patients received 1 placebo pill 2 times daily. All subjects received medications for 6 months. The chi-squared or Fisher exact tests were used to assess drug efficacy with respect to objective findings and symptoms. Results A greater percentage of individuals in the clofazimine group had no further aphthous episodes (17%-44% compared with ≤6% in the other groups). A significantly greater percentage of treatment interruption occurred in the colchicine group because of gastrointestinal effects (23%-45%). Individuals in the clofazimine group who continued to suffer from aphthous stomatitis presented with better results for the evaluated variables. Conclusion Clofazimine should be considered for the treatment of recurrent aphthous stomatitis.