Evaluation of cepharanthin in oral lichen planus for the efficacy and safety: A multicenter randomized controlled study

Yagyuu Takahiro0 个研究点目标入组 50 人开始时间: 2022年12月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)20 years old or over
•2)Patients with oral lichen planus diagnosed clinically and histopathologically,
•3)Patients with oral lichen planus with moderate or higher (Grade 2 or 3) pain in the severity classification of CTCAE v5.0
•4)Patients with ECOG Performance Status (PS) of 0-3
•5)Patients providing the written informed consent

•1. Patients with previous treatment of cepharanthin
•2. Patients with a history of radiotherapy in the oral cavity
•3. Patients receiving or having a plan to receive systemic administration of anticancer drugs, immunosuppressants and analgesic drugs.
•4. Patients with a history of hypersensitivity to dexamethasone oral ointment
•5. Pregnant women and women suspected of being pregnant
•6. Lactating women
•7. Patients with severe liver disfunction (AST, ALT and GTP >= 5.0 times the upper limit of the standard value, T-Bil >= 3.0 times the upper limit of the institutional standard value)
•8. Patients who are unlikely to provide effective informed consent
•9. Any other patients who are regarded as unsuitable for this study by the investigators.

发起方

Yagyuu Takahiro