AbobotulinumtoxinA Treatment of Glabellar Lines Using a New Reconstitution and Injection Volume: Randomized, Placebo-Controlled Data
| Autor: | Daniel P. Friedmann, Flor A Mayoral, Douglas C. Wu, Keith Marcus, Deanne Mraz Robinson, Michael Somenek, DeeAnna Glaser, Xiaoming Lin, Joel Schlessinger |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Health professionals Adolescent business.industry General Medicine Middle Aged Placebo Responder rate Skin Aging Young Adult Treatment Outcome Double-Blind Method Neuromuscular Agents Patient Satisfaction Anesthesia Injection site Injection volume Clinical endpoint Medicine Humans Forehead Botulinum Toxins Type A business Duration of effect Time to onset |
| Zdroj: | Journal of drugs in dermatology : JDD. 20(9) |
| ISSN: | 1545-9616 |
| Popis: | Background Increasing the reconstitution and injection volumes of abobotulinumtoxinA (aboBoNT-A) could provide more options for aesthetic healthcare professionals. Objective To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume. Methods a Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.1-mL-injections (10 U) in the glabellar region following reconstitution of a 300-U-vial in 3 mL. Assessments included time to onset of effect, investigator- (ILA) and subject- (SSA) assessed GL severity, subject satisfaction, aesthetic improvement and safety. The primary endpoint was composite 2-grade response at month 1 (a GL severity of none-or-mild at maximum frown and g2-grade improvement from baseline concurrently on both ILA and SSA). Results Median time to onset was 2 days, 34% of subjects reporting effect on day 1. At month 1, the composite 2-grade responder rate was 65.8% for aboBoNT-A versus 0% for placebo, Pl0.001, 91n92% had none-or-mild GL severity, and 95n100% had a g1-grade GL severity improvement. A g1-grade improvement was sustained in 46-56% of aboBoNT-A-treated subjects up to 6 months (Pl0.001 vs placebo). Aesthetic improvement and subject satisfaction were high throughout 6 months and aboBoNT-A treatment was well tolerated. Conclusion Safety and efficacy of GL treatment using 0.1 mL (10 U) aboBoNT-A per injection site were demonstrated, with rapid onset and up to 6 monthsr duration of effect. Severity improvement was accompanied by sustained aesthetic improvement and subject satisfaction. J Drugs Dermatol. 2021;20(9):988-995. doi:10.36849/JDD.6130. |
| Databáze: | OpenAIRE |
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