Efficacy and Durability of the Association of Botox and Skinvive in the Treatment of Moderate/Severe Wrinkles in the Periorbital Region: A Randomized, Controlled, Double-Blind, Split-Face Clinical Study.

BACKGROUND

The combined efficacy and durability of botulinum toxin A (BTX) and hyaluronic acid fillers (HA) for canthal wrinkles have not been thoroughly evaluated in randomized clinical trials.

AIMS

This study evaluated the efficacy, safety, and durability of the combined treatment protocol of onabotulinumtoxinA and Juvederm Volite VYC-12 (Skinvive) for moderate and severe canthal lines.

METHODS

This randomized double-blinded split-face trial included 25 women with periorbital dynamic wrinkles at severity levels II-IV according to the Merz 5-point scale. After bilateral onabotulinummtoxinA injections, the sides of the participants' faces were randomized to receive HA injections or a simulated injection. Assessed variables included electromyography activity (EMG), Merz 5-point crow's feet scale, and FACE-Q appraisal on crow's feet lines. Assessments were performed at baseline, 1, 2, 3, and 6 months. For differences in EMG and satisfaction scores, the two-way repeated measures ANOVA and Bonferroni's post hoc analyses were conducted. Wrinkle severity scores were analyzed with the Mann-Whitney U test.

RESULTS

Inter-treatment comparisons revealed no significant differences between treatment protocols in all assessed periods for EMG (p = 0.86). For severity of canthal wrinkles, onabotulinumtoxinA + VYC-12 exhibited lower canthal wrinkle severity in rest and contracted positions after 3 (p = 0.04), and 3 (p = 0.007) and 6 (p = 0.001) months, respectively. Additionally, satisfaction with BTX-HA treatment was significantly higher after 3-month (p = 0.001) and 6-month (p = 0.001) follow-ups compared to BTX treatment.

CONCLUSIONS

Higher improvements in canthal wrinkles could be enhanced by using onabotulinumtoxinA and VYC-12 in association as a treatment protocol.