Double-blind, randomized non-inferiority trial of a novel botulinum toxin A processed from the strain CBFC26, compared with onabotulinumtoxin A in the treatment of glabellar lines

초록

BackgroundBotulinum toxins have been widely used in cosmetic dermatology. Neurotoxin from the CBFC26 strain (NTC) is a recently developed botulinum toxin type A product manufactured through refined procedures. ObjectiveA double-blinded, randomized, multicentre-designed, phase III trial to investigate the non-inferiority of NTC to existing botulinum toxin A, onabotulinumtoxin A in the treatment of moderate to severe glabellar lines. MethodsA total of 272 subjects were randomized in a 1:1 ratio to receive 20U of NTC or onabotulinumtoxin A. The primary endpoint was the response rate of physicians' assessment (PA) using the Facial Wrinkle Scale at week 4. The secondary endpoints included the response rate of PA at weeks 8, 12 and 16, and photographic assessment at weeks 4, 8, 12 and 16. Subjects' improvement assessment and subjective self-satisfaction levels were also investigated. ResultsResponse rates for maximum frown were 89.3% in the NTC group and 81.9% in the onabotulinumtoxin A group at week 4. NTC also resulted in comparable results for both the response rates of the other evaluation points and incidence of adverse events compared to those of onabotulinumtoxin A. In subjects' improvement assessment and photographic evaluations, NTC even demonstrated better results compared with onabotulinumtoxin A in the early phase after treatment. Analysis of these results strongly supports the non-inferiority of NTC to onabotulinumtoxin A in the efficacy and safety. ConclusionNTC is as effective as onabotulinumtoxin A in the treatment of glabellar lines, and both products were well tolerated.

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