Randomized clinical trial of imiquimod compared with fludroxycortide in the treatment of actinic cheilitis.

OBJECTIVE: Actinic cheilitis (AC) is a potentially malignant disorder of the lip vermillion. The study of effective therapeutic options is of the utmost importance to prevent the development of lip squamous cell carcinoma. This study aimed to evaluate the topical effect of imiquimod 5% (IM) and fludroxycortide (FC) 0.125 mg/g creams in the treatment of AC. STUDY DESIGN: A randomized controlled trial was conducted. Twenty-five participants of both genders, with a clinical diagnosis of AC, were divided into IM (n=13) and FC (n=12) groups. The treatment duration was six weeks for both groups. Participants were followed up by regular visits for clinical examination and photographic documentation. RESULTS: At the end of 180 days, the clinical outcomes were evaluated. In the IM group, there was a significant improvement in AC after 180 days of follow-up (P = .005). In the FC group, there was no significant improvement (P = .317). There was a significant difference between the groups in the clinical outcomes (P = .000). CONCLUSION: This study suggests that imiquimod may be a treatment option for AC in more advanced clinical cases, but local reactions should be expected. Conversely, fludroxycortide demonstrated no clinical efficacy, and therefore, should be avoided in AC cases presenting with leukoplakia.