Efficacy and Safety of Combined Topical Lidocaine and Tetracaine Cream for Facial Fractional Laser Resurfacing Compared With Its Reference Product in Chinese Adults: A Multicenter, Randomized, Double-Blind Phase 3 Study.

BACKGROUND

As a potentially effective anesthetic, CU-30101 is comprised of 7% lidocaine and 7% tetracaine and is a generic drug of Pliaglis. This study aimed to investigate the equivalence between CU-30101 and Pliaglis as topical anesthetics for fractional laser.

METHODS

This Phase 3 trial recruited Chinese adults scheduled for facial fractional laser resurfacing. Participants were randomized to receive opposite treatment sequences of CU-30101 and Pliaglis on contralateral sides of the face prior to laser application. Visual Analog Scale (VAS), participant and investigator satisfaction ratings, local tolerability, and safety were assessed.

RESULTS

Two hundred eighty-four participants completed the study, with mean VAS scores of 35.3 ± 24.51 for CU-30101 and 37.3 ± 24.17 for Pliaglis. The 95% confidence interval of -3.78 to -0.13 for the VAS difference laid within the predefined equivalence margin of ±4.7, confirming equivalence in efficacy. The results in the per-protocol set further corroborated the equivalence. Both participants and investigators expressed consistently high satisfaction with CU-30101 and Pliaglis. Furthermore, both treatments were well tolerated and exhibited favorable safety profiles.

CONCLUSION

This study demonstrated the equivalent efficacy of CU-30101 to its reference product, Pliaglis, among Chinese adults undergoing facial fractional laser resurfacing. CU-30101 showed commendable local tolerability and safety profiles, consistent with those of Pliaglis.