Efficacy and Safety of IncobotulinumtoxinA in Asian Subjects: A Pooled Analysis of Clinical Trials in the Treatment of Glabellar Frown Lines
September 2016 | Volume 15 | Issue 9 | Original Article | 1084 | Copyright © September 2016
Kyle Seo MD PhD,a,b Tsen-Fang Tsai MD,c Yates Yen-Yu Chao MD,d Greg J. Goodman FACDe,f
aModelo Clinic, Seoul, Korea
bDepartment of Dermatology, Seoul National University College of Medicine, Seoul, Korea
cDepartment of Dermatology, National Taiwan University Hospital, Taipei, Taiwan
dL1 Cosmetic Surgery and Laser Center, Taipei, Taiwan
eDepartment of General Practice, Monash University, Clayton, Victoria, Australia
fSkin and Cancer Foundation, Carlton, Victoria, Australia
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.
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.
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.
J Drugs Dermatol. 2016;15(9):1084-1087.