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

B. J. Kim, H. H. Kwon, S. Y. Park, S. U. Min, J. Y. Yoon, Y. M. Park, S. H. Seo, J. Y. Ahn, H. K. Lee, Dae Hun Suh

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background Botulinum 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.

Objectives A 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.

Methods A total of 272 subjects were randomized in a 1: 1 ratio to receive 20 U 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.

Results Response 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. Conclusion NTC is as effective as onabotulinumtoxin A in the treatment of glabellar lines, and both products were well tolerated.

Original languageEnglish
Pages (from-to)1761-1767
Number of pages7
JournalJournal of the European Academy of Dermatology and Venereology
Volume28
Issue number12
DOIs
StatePublished - 1 Jan 2014

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Type A Botulinum Toxins
Therapeutics
Physicians
Botulinum Toxins
Neurotoxins
Dermatology
onabotulinumtoxinA
Cosmetics
Safety
Incidence

Cite this

@article{dddeb5315dac46fa85a564d57b9616ca,
title = "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",
abstract = "Background Botulinum 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.Objectives A 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.Methods A total of 272 subjects were randomized in a 1: 1 ratio to receive 20 U 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.Results Response 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. Conclusion NTC is as effective as onabotulinumtoxin A in the treatment of glabellar lines, and both products were well tolerated.",
author = "Kim, {B. J.} and Kwon, {H. H.} and Park, {S. Y.} and Min, {S. U.} and Yoon, {J. Y.} and Park, {Y. M.} and Seo, {S. H.} and Ahn, {J. Y.} and Lee, {H. K.} and Suh, {Dae Hun}",
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journal = "Journal of the European Academy of Dermatology and Venereology",
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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. / Kim, B. J.; Kwon, H. H.; Park, S. Y.; Min, S. U.; Yoon, J. Y.; Park, Y. M.; Seo, S. H.; Ahn, J. Y.; Lee, H. K.; Suh, Dae Hun.

In: Journal of the European Academy of Dermatology and Venereology, Vol. 28, No. 12, 01.01.2014, p. 1761-1767.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Kim, B. J.

AU - Kwon, H. H.

AU - Park, S. Y.

AU - Min, S. U.

AU - Yoon, J. Y.

AU - Park, Y. M.

AU - Seo, S. H.

AU - Ahn, J. Y.

AU - Lee, H. K.

AU - Suh, Dae Hun

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background Botulinum 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.Objectives A 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.Methods A total of 272 subjects were randomized in a 1: 1 ratio to receive 20 U 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.Results Response 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. Conclusion NTC is as effective as onabotulinumtoxin A in the treatment of glabellar lines, and both products were well tolerated.

AB - Background Botulinum 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.Objectives A 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.Methods A total of 272 subjects were randomized in a 1: 1 ratio to receive 20 U 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.Results Response 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. Conclusion NTC is as effective as onabotulinumtoxin A in the treatment of glabellar lines, and both products were well tolerated.

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U2 - 10.1111/jdv.12408

DO - 10.1111/jdv.12408

M3 - Article

C2 - 24593323

AN - SCOPUS:84911997808

VL - 28

SP - 1761

EP - 1767

JO - Journal of the European Academy of Dermatology and Venereology

JF - Journal of the European Academy of Dermatology and Venereology

SN - 0926-9959

IS - 12

ER -