Efficacy and Safety of IncobotulinumtoxinA in Asian Subjects: A Pooled Analysis of Clinical Trials in the Treatment of Glabellar Frown Lines.

[BACKGROUND] Owing to differences in facial anatomy and cultural beauty ideals, dose adaptations are often necessary when administering botulinum toxin type A to Asians and non-Asians.

[OBJECTIVE] To assess potential differences in the efficacy and safety of incobotulinumtoxinA in Asian and non-Asians.<br/>

[METHODS] Efficacy data were pooled from several Phase II/III trials that used 20 U incobotulinumtoxinA to treat glabellar frown lines in Asian subjects. The variable of interest was investigator-assessed improvement in scores on the 4-point Facial Wrinkle Scale from baseline to days 30, 60, 90, and 120. Subjects with a 1-point improvement were considered 'responders'. Data were also assessed for treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest among a pool of incobotulinumtoxinA safety studies.<br/>

[RESULTS] Four trials were pooled, comprising 19 Asian and 563 non-Asian subjects. At maximum frown on day 30, 100% of Asians and 87% of non-Asians were responders; by day 120, values were 37% and 40%, respectively. At rest on day 30, 63% of Asians and 56% of non-Asians were responders. Corresponding values for day 120 were 11% and 25%. The mean change in score on the Facial Wrinkle Scale from baseline over time was similar in both groups. Very few adverse events occurred. Overall, treatment-emergent adverse events were lower amongst Asians than non-Asians.<br/>

[CONCLUSIONS] Compared with non-Asians, a trend towards slightly higher responses was observed in Asians at maximum frown. There were no clinically relevant differences in the safety of incobotulinumtoxinA when administered to Asian and non-Asian subjects. <br /><br /> <em>J Drugs Dermatol.</em> 2016;15(9):1084-1087.