Background: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.
Objectives: The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines.
Methods: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30.
Results: Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related.
Conclusions: A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.
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http://dx.doi.org/10.1093/asj/sjz110 | DOI Listing |
BMJ Open
January 2025
Siriraj Health Policy Unit, Mahidol University Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
Objectives: To evaluate the cost-utility of botulinum toxin A (BoNT-A) for treating upper limb (UL) and lower limb (LL) post-stroke spasticity.
Design: Using a Markov model, adopting a societal perspective and a lifetime horizon with a 3% annual discount rate, the cost-utility analysis was conducted to compare BoNT-A combined with standard of care (SoC) with SoC alone. Costs, utilities, transitional probabilities and treatment efficacy were derived from 5-year retrospective data from tertiary hospitals and meta-analysis.
Dermatol Surg
September 2024
Evolus Inc., Newport Beach, California.
Background: Millennials accept and invest in aesthetic procedures more than older generations.
Objective: To compare efficacy outcomes between millennial and nonmillennial patients after treatment of glabellar lines with prabotulinumtoxinA.
Materials And Methods: This was a post hoc analysis of 3 Phase III studies of 20 U prabotulinumtoxinA for the treatment of moderate to severe glabellar lines.
J Cosmet Dermatol
October 2024
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
Background: Botulinum toxin A (BoNT-A) is widely utilized in the management of hypertrophic and keloid scars. One proposed mechanism for scar prevention involves the inhibition of fibroblast migration in scars by BoNT-A. However, the data regarding the effect of BoNT-A on the migration of normal human dermal fibroblasts (NHDF) is limited.
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