Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of a New Botulinum Toxin (HU-014) Versus OnabotulinumtoxinA in Subjects With Moderate-to-Severe Crow's Feet Lines.

BACKGROUND

HU-014, a newly introduced botulinum toxin type A, has not been investigated for its efficacy and safety in crow's feet line (CFL) treatment.

OBJECTIVE

Here, we compared the efficacy and safety of HU-014 and onabotulinumtoxinA in CFL treatment.

METHODS

This was a randomized, double-blind, active drug-controlled, multicenter, 16-week, Phase I/III study designed to determine the noninferiority of HU-014 compared with onabotulinumtoxinA in moderate-to-severe CFL treatment. In the Phase III study, 290 subjects were randomized at a 1:1 ratio to receive a single treatment of HU-014 or onabotulinumtoxinA. The primary endpoint was the proportion of subjects achieving Grade 0 or 1 in the facial wrinkle scale on maximum smile at Week 4.

RESULTS

The primary endpoint was achieved by 72% of the subjects with HU-014 and onabotulinumtoxinA treatments, supporting the noninferiority of HU-014 compared with onabotulinumtoxinA. All secondary efficacy outcomes were achieved by the subjects. The 2 groups showed no significant differences in the safety analysis.

CONCLUSION

HU-014 has noninferior efficacy and safety compared with onabotulinumtoxinA in the treatment of CFL.