A Randomized, Comparative Study to Evaluate Efficacy and Safety of Two Injection Volumes of AbobotulinumtoxinA in Treatment of Glabellar Lines

作者：Punga Anna Rostedt^*; Alimohammadi Mohammad; Fagrell Dan; Nyberg Frida; Rees Diane; Wong Cindy

来源：Dermatologic Surgery, 2016, 42(8): 967-976.

DOI：10.1097/DSS.0000000000000805

BACKGROUNDDifferent volumes of 0.9% NaCl may be used to reconstitute abobotulinumtoxinA yielding an injection volume that ranges from 0.05 to 0.1 mL per injection point for treatment of glabellar lines.OBJECTIVETo evaluate the efficacy, safety, and subject satisfaction of 2 different injection volumes to deliver the same unit dose of abobotulinumtoxinA for treatment of glabellar lines.MATERIALS AND METHODSThis randomized comparative study was conducted using 2 different reconstitution volumes to deliver a fixed unit dose of 10 Speywood units (sU) of abobotulinumtoxinA in either 0.05 mL (labeled volume) or 0.1 mL (twofold volume) per injection point. Evaluations included wrinkle severity, neurophysiological assessment by compound muscle action potential (CMAP), and subject satisfaction.RESULTSUse of either injection volume of abobotulinumtoxinA resulted in the early onset of effect, high effectiveness, and long duration of effect. The safety profile and injection pain levels were similar in both groups. The twofold injection volume was shown to be noninferior to the labeled injection volume based on CMAP results.CONCLUSIONA twofold increase in injection volume to 0.1 mL per injection point to deliver 10 sU of abobotulinumtoxinA is effective and safe.

• 出版日期2016-8