Efficacy and Safety of CKDB-501A in Treating Moderate-To-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center Phase III Trial.

Summary

In a multicenter, double-blind phase III trial (n=300), an animal-component–free botulinum toxin (CKDB-501A) demonstrated non-inferiority to onabotulinumtoxinA for glabellar lines with 80.69% vs 70.83% achieving ≥2-point FWS improvement at week 4. Efficacy was sustained to 16 weeks, and no neutralizing antibodies or hypersensitivity events were observed.

Key Findings

• Week-4 ≥2-point FWS improvement: CKDB-501A 80.69% vs onabotulinumtoxinA 70.83% (non-inferior; 95% CI 0.09–19.55; p=0.0491).
• Sustained efficacy through 16 weeks with ~70% maintaining ≥1-point improvement.
• Comparable safety; no events from local/distant spread, no hypersensitivity, and no neutralizing antibodies detected.
• Secondary photo-assessed and subject-reported outcomes aligned with primary efficacy.

Clinical Implications

CKDB-501A can be considered an effective alternative to onabotulinumtoxinA for moderate-to-severe glabellar lines, with the potential advantage of avoiding human serum albumin and minimizing hypersensitivity/antibody concerns. Clinicians may expect comparable 4–16 week efficacy profiles.

Limitations

• Single treatment cycle with follow-up limited to 16 weeks
• Non-inferiority framework; superiority and long-term immunogenicity not established

Future Directions

Evaluate durability across repeated cycles, dose–response equivalence, real-world safety, and subgroup responses (e.g., prior toxin exposure, diverse skin types).