Abstract
BACKGROUND: Botulinum toxin is a key treatment for dynamic wrinkles. OBJECTIVE: This study evaluates CKDB-501A, a botulinum toxin completely free from animal-derived components including human-serum albumin, comparing its efficacy and safety to onabotulinumtoxinA (ONA) for the treatment of moderate-to-severe glabellar lines. METHODS: In this phase 3 trial, 300 subjects with moderate-to-severe glabellar lines were randomized to receive CKDB-501A or ONA. The primary efficacy endpoint was the investigator-assessed improvement rate for frowning at week 4, defined as a ≥ 2-point improvement from baseline on the 4-point Facial Wrinkle Scale (FWS). Secondary efficacy endpoints included photo-assessed improvement rates and subjects' overall assessment and satisfaction. Safety was evaluated by the monitoring of adverse events (AEs) and neutralizing antibodies formation. RESULTS: At week 4, 80.69% of the CKDB-501A group achieved a ≥ 2-point improvement in FWS score versus 70.83% for ONA, confirming non-inferiority (95% CI: 0.09-19.55, p = 0.0491). Secondary endpoints showed no significant differences between groups, with sustained efficacy up to 16 weeks. Approximately 70% maintained at least a 1-point improvement. Photo-assessed and subjects' overall improvement and satisfaction rates were consistent with primary findings. Both treatments had comparable safety profiles, with no AEs related to the local and distant spread of toxin, hypersensitivity reactions, or neutralizing antibodies formation. CONCLUSION: CKDB-501A is a safe and effective alternative to existing botulinum toxin products for treating moderate-to-severe glabellar lines, offering benefits of improved biocompatibility and reduced risk of allergic reactions. CLINICALTRIALS: gov: NCT05804656.