AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study

September 2021 | Volume 20 | Issue 9 | Original Article | 980 | Copyright © September 2021


Published online August 16, 2021

John Joseph MD,a Amir Moradi MD MBA,b Z. Paul Lorenc MD FACS,c Kyle Coleman MD,d Glynis Ablon MD FAAD,e Joely Kaufman-Janette MD,f Sue Ellen Cox MD,g Andrew Campbell MD,h Steven Dayan MD,i Anna-Karin Berg PhD,j Girish Munavalli MD MHS FACMSk

aClinical Testing of Beverly Hills, Encino, CA
bMoradi M.D., Vista, CA
cLorenc Aesthetic Plastic Surgery Center, New York, NY
dEtre Cosmetic Dermatology and Laser Center, New Orleans, LA
eAblon Skin Institute and Research Center, Manhattan Beach, CA
fSkin Research Institute, LLC, Coral Gables, FL
gAesthetic Solutions, PA, Chapel Hill, NC
hQuintessa Aesthetic Center – Ethiq2 Research, LLC, Mequon, WI
iDeNova Research, Chicago, IL
jGalderma, Uppsala, Sweden
kDermatology, Laser & Vein Specialists of the Carolinas, PLLC, Charlotte, NC

RESULTS

Study Population
In total, 401 subjects were randomized and 399 received ABO or placebo. Each of the ABO 50, 75 and 100 U groups included 80 subjects, 81 received the ABO 125 U dose, and 78 were given placebo. Overall, 369 (92.0%) randomized subjects completed the study. One subject withdrew due to concerns relating to the COVID-19 pandemic, 14 discontinued prematurely for other reasons and 15 individuals were lost to follow-up.

Table 1 shows baseline demographics and characteristics. Most subjects were female (88.2%) and White (87.2%). Mean (standard deviation [SD]) age was 48.4 (10.68) years (range, 22–65 years). The majority had severe glabellar lines when assessed using ILA (67.9%) and SSA (71.7%) scales.

Primary Endpoint
Week 4 composite ≥2-grade responder rate with ABO 50, 75,
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