[Translation] A randomized, positive self-controlled, double-blind, multicenter, equivalence clinical study on the efficacy and safety of lidocaine tetracaine cream for local anesthesia of intact skin before superficial skin surgery in adults
以原研药 PLIAGLIS ®为阳性对照,通过随机、双盲、自身对照的临床试验,验证试验药物利多卡因丁卡因乳膏用于成人浅层皮肤手术前对完整皮肤局部麻醉的有效性。 通过实验室检查、临床症状、体征、不良事件等,验证利多卡因丁卡因乳膏的安全性。
[Translation] Using the original drug PLIAGLIS ® as a positive control, a randomized, double-blind, self-controlled clinical trial was conducted to verify the effectiveness of the experimental drug lidocaine tetracaine cream for local anesthesia of intact skin before superficial skin surgery in adults. The safety of lidocaine tetracaine cream was verified through laboratory tests, clinical symptoms, signs, adverse events, etc.