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.
Kyle
K
Seo
Tsen-Fang
TF
Tsai
Yates Yen-Yu
YY
Chao
Greg J
GJ
Goodman
D044466:Asian People / Q000208:ethnology*; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D005546:Forehead / Q000033:anatomy & histology / Q000473:pathology; D006801:Humans; D015595:Skin Aging / Q000187:drug effects* / Q000208:ethnology* / Q000473:pathology; D016896:Treatment Outcome
D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA