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科笛-B(02487):CU-30101(局部外用利多卡因丁卡因乳膏剂)中国III期临床试验结果获第30次CSD年会接受以电子壁报形式展示
智通财经网· 2025-06-26 23:53
Core Viewpoint - The clinical trial results for CU-30101, a topical anesthetic cream, have been accepted for presentation at the 30th CSD Annual Meeting, highlighting the company's influence and cutting-edge research in the dermatology field [1] Group 1: Clinical Trial Overview - The Phase III clinical trial was a multi-center, randomized, double-blind, positive drug-controlled study designed to evaluate the safety and efficacy of CU-30101 for local anesthesia in dermatological procedures [1] - The trial used Pliaglis® as a comparator, with the primary efficacy endpoint being the visual analog scale (VAS) for pain immediately after fractional laser surgery [1] Group 2: Efficacy Results - The results showed that the VAS difference between the two sides of the face (CU-30101 side vs. Pliaglis® side) fell within the predefined equivalence range, indicating comparable analgesic efficacy [2] - No statistically significant differences were found in patient evaluations regarding pain relief, likelihood of reusing the drug, and researchers' satisfaction with the efficacy of both drugs (P > 0.05) [2] Group 3: Safety Profile - CU-30101 demonstrated good overall safety with no severe adverse events reported [2] - The local tolerability assessment of CU-30101 was similar to that of Pliaglis®, consistent with known safety characteristics, and no new safety signals were identified [2] Group 4: Regulatory Progress - Based on the Phase III trial results, the company has submitted a drug marketing application for CU-30101 to the National Medical Products Administration, which is expected to be accepted by July 2024 [2]