A randomized double-blind non-inferiority trial comparing LUCENTRA with DYSPORT for moderate-to-severe glabellar line improvement

Botulinum toxin type A (BoNT-A) formulations are widely used for the treatment of glabellar lines, with DYSPORT being a well-established option; however, its high cost limits accessibility. LUCENTRA, a newly developed BoNT-A, may offer a more affordable alternative. This phase III, randomized, double-blind, active-controlled non-inferiority clinical trial evaluated the efficacy and safety of LUCENTRA compared with DYSPORT in participants with moderate to severe glabellar lines. Participants received 40–60 units of intramuscular injections of either formulation, and the primary endpoint was the proportion of responders at day 30, defined as a ≥ 2-grade improvement on the glabellar line severity score at maximum frown. Secondary endpoints included onset of action at maximum frown, response rates based on the glabellar line severity scale, and subject self-assessment at maximum frown and rest, and safety was assessed on days 14, 30, 90, and 120. A total of 146 participants were enrolled (73 per arm). LUCENTRA was non-inferior to DYSPORT, with responder rates of 69% and 60.8%, respectively (95% CI: − 7.0 to 24.7%). Median onset was four days for LUCENTRA and five days for DYSPORT. Adverse events, mainly mild headaches and injection site discomfort, were comparable, and no serious events occurred. LUCENTRA is non-inferior to DYSPORT in terms of improving glabellar lines at day 30 post-injection, supporting its efficacy as an alternative option of DYSPORT. Adverse events were also comparable between the two groups suggesting safety and tolerability of DYSPORT and LUCENTRA.