By Fineline Cube 
Cutia Therapeutics (HKG: 2487), a dermatology specialist, is set to present the Phase III clinical trial results of its CU-30101, a topical anesthetic lidocaine-tetracaine cream for superficial dermatologic procedures, at the 30th Annual Meeting of the Chinese Society of Dermatology (CSD) via an e-poster presentation.
Trial Design
The multicenter, randomized, double-blind, active-controlled, paired Phase III study assessed the safety and efficacy of CU-30101 for post-fractional laser analgesia, with Pliaglis as the control.
Key Findings
The study demonstrated CU-30101’s non-inferiority to Pliaglis, with pain score differences between treatment areas falling within the predefined equivalence margin. No statistically significant differences were observed in efficacy ratings, willingness for re-use, or treatment satisfaction. CU-30101 showed good overall safety with no serious adverse events and local tolerability comparable to Pliaglis.
Regulatory Action
These results supported Cutia’s New Drug Application (NDA) filing with China’s National Medical Products Administration (NMPA), which was accepted for review in July 2024.-Fineline Info & Tech