Treatment of recurrent aphthous stomatitis with clofazimine

Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):714-21. doi: 10.1016/j.tripleo.2009.05.009. Epub 2009 Aug 20.


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 <or=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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Clofazimine / therapeutic use*
  • Colchicine / therapeutic use
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement
  • Single-Blind Method
  • Stomatitis, Aphthous / drug therapy*
  • Young Adult


  • Anti-Inflammatory Agents, Non-Steroidal
  • Clofazimine
  • Colchicine