1. Feasibility of cinobufacini for the treatment of oral premalignant lesions: an open-label pilot trial
- Author
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Yang Liu, Ping Huang, Jie Ming, Yuhong Wang, Yuanyuan Wang, Minghui Wei, Yuan Cui, Jiao Wei, and Xinwen Wang
- Subjects
cinobufacini ,oral potentially malignant disorders ,potentially premalignant oral epithelial lesions ,oral lichen planus ,oral leukoplakia ,Other systems of medicine ,RZ201-999 - Abstract
Aim: This study aimed to explore the feasibility and preliminary efficacy of cinobufacini in patients with oral premalignant lesions (OPLs). Methods: Patients with histologically confirmed OPLs participated in an open-label uncontrolled pilot clinical study and received a 4-week or 12-week treatment, the efficacy and safety of cinobufacini for the treatment of OPLs were assessed. Results: During the treatment course ranging from 4 weeks to 12 weeks, no one withdrew because of adverse effects, no one had clinical or histologic progressive disease. Of the 8 participants who took cinobufacini for 12 weeks, one had a complete clinical response, and 4 had a complete histologic response. Of note, 9 participants had varying degrees of pain reduction. Conclusions: This small pilot study supports the feasibility of a larger clinical trial to evaluate the efficacy of cinobufacini in the treatment of OPLs [Chinese Clinical Trial Registry (chictr.org.cn) identifier: ChiCTR2300068529].
- Published
- 2025
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