Efficacy and safety of a novel botulinum toxin type A product for the treatment of moderate to severe glabellar lines: a randomized, double-blind, active-controlled multicenter study.

Chong H. Won, Hyung M. Lee, Woo S. Lee, Hoon Kang, Beom J. Kim, Won S. Kim, JuHee Lee, Dong H. Lee, Chang H. Huh

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

A new botulinum toxin type A (NBoNT) produced from the same strain of Clostridium botulinum as onabotulinumtoxinA (OBoNT) is widely used in Asia. To compare the efficacy and safety of NBoNT and OBoNT for moderate to severe glabellar wrinkles. A double-blind, randomized, active-controlled, phase III study was performed. Three hundred fourteen patients were randomized at a 1:1 ratio to receive 20 U of toxin. The primary end point was the responder rate according to investigator live assessment at maximum frown at week 4. Secondary end points were responder rates according to investigator live assessment with frowning and at rest at weeks 8, 12, and 16, with additional photographic assessment by a panel of blinded raters 4 weeks after injection. Subjective satisfaction scores were also evaluated. Four weeks after treatment, responder rates for maximum frown were 93.7% (133/142) in the NBoNT group and 94.5% (138/146) in the OBoNT group. For secondary end points, there was no significant difference between the two groups for any variable at any time point. Noninferiority of NBoNT was confirmed. There were no serious adverse effects with either toxin. NBoNT is equally as effective as OBoNT for the treatment of glabellar frown lines. Both toxins were well tolerated.

Original languageEnglish
Pages (from-to)171-178
Number of pages8
JournalUnknown Journal
Volume39
Issue number1 Pt 2
Publication statusPublished - 2013 Jan 1

Fingerprint

Type A Botulinum Toxins
Multicenter Studies
Safety
Research Personnel
Clostridium botulinum
Therapeutics
Efficacy
Injections
onabotulinumtoxinA

All Science Journal Classification (ASJC) codes

  • Surgery
  • Dermatology

Cite this

Won, Chong H. ; Lee, Hyung M. ; Lee, Woo S. ; Kang, Hoon ; Kim, Beom J. ; Kim, Won S. ; Lee, JuHee ; Lee, Dong H. ; Huh, Chang H. / Efficacy and safety of a novel botulinum toxin type A product for the treatment of moderate to severe glabellar lines : a randomized, double-blind, active-controlled multicenter study. In: Unknown Journal. 2013 ; Vol. 39, No. 1 Pt 2. pp. 171-178.
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abstract = "A new botulinum toxin type A (NBoNT) produced from the same strain of Clostridium botulinum as onabotulinumtoxinA (OBoNT) is widely used in Asia. To compare the efficacy and safety of NBoNT and OBoNT for moderate to severe glabellar wrinkles. A double-blind, randomized, active-controlled, phase III study was performed. Three hundred fourteen patients were randomized at a 1:1 ratio to receive 20 U of toxin. The primary end point was the responder rate according to investigator live assessment at maximum frown at week 4. Secondary end points were responder rates according to investigator live assessment with frowning and at rest at weeks 8, 12, and 16, with additional photographic assessment by a panel of blinded raters 4 weeks after injection. Subjective satisfaction scores were also evaluated. Four weeks after treatment, responder rates for maximum frown were 93.7{\%} (133/142) in the NBoNT group and 94.5{\%} (138/146) in the OBoNT group. For secondary end points, there was no significant difference between the two groups for any variable at any time point. Noninferiority of NBoNT was confirmed. There were no serious adverse effects with either toxin. NBoNT is equally as effective as OBoNT for the treatment of glabellar frown lines. Both toxins were well tolerated.",
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Efficacy and safety of a novel botulinum toxin type A product for the treatment of moderate to severe glabellar lines : a randomized, double-blind, active-controlled multicenter study. / Won, Chong H.; Lee, Hyung M.; Lee, Woo S.; Kang, Hoon; Kim, Beom J.; Kim, Won S.; Lee, JuHee; Lee, Dong H.; Huh, Chang H.

In: Unknown Journal, Vol. 39, No. 1 Pt 2, 01.01.2013, p. 171-178.

Research output: Contribution to journalArticle

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AU - Won, Chong H.

AU - Lee, Hyung M.

AU - Lee, Woo S.

AU - Kang, Hoon

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AU - Huh, Chang H.

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