Safety and efficacy evaluation of botulinum toxin an injection by FITTER® microneedle to treat medial lower eyelid wrinkles.

[BACKGROUND] Treatment for medial lower eyelid wrinkles is in great demand now. However, conventional injection of botulinum toxin A (BTX-A) often leads to serious complications.

[AIMS] We aim to evaluate the safety and efficacy of BTX-A injection with microneedle to treat medial lower eyelid wrinkles.

[METHODS] We collected clinical data of 16 patients to treat dynamic wrinkles on the medial aspect of the lower eyelid. Adverse effects at each stage of the treatment were recorded. We used VISIA to compare the static and dynamic wrinkles of the medial lower eyelid before and after treatment. Furthermore, patients and physicians evaluated the wrinkles with Kappa scores.

[RESULTS] All 16 patients completed the study. The objective evaluation indicator (the Ra variable given by VISIA) progressively and significantly decreased at 1 month and 3 months after treatment. The kappa scores given by patients and by surgeons were both significantly reduced after treatment. No adverse reactions, such as pouch prolapse, diplopia, and canthal tendon laxity, occurred at 1 week, 1 month, or 3 months after the treatment.

[CONCLUSION] BTX-A treatment of medial lower eyelid wrinkles with microneedle injection allows better control of the injection depth and reduces both the amount of BTX-A needed and the incidence of complications while maintaining the natural dynamic expression.