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.