Safety and Duration of Effect of 40-Unit PrabotulinumtoxinA-xvfs for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients: A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Trial.
Aesthet Surg J
; 44(9): 987-1000, 2024 Aug 20.
Article
em En
| MEDLINE
| ID: mdl-38506148
ABSTRACT
BACKGROUND:
Extending the duration of effect of botulinum toxins-by administering doses beyond those of the approved labels-has been an area of increasing interest in the field of aesthetics.OBJECTIVES:
The aim of this study was to investigate the safety and duration of effect of 40-unit (U) prabotulinumtoxinA-xvfs (twice the approved dose and concentration) for the treatment of moderate-to-severe glabellar lines.METHODS:
A total of 154 adult patients were randomized 111 to a single treatment of either 40â U prabotulinumtoxinA-xvfs (PRA 40, 5 injections of 8â U/0.05â mL), or 20â U of either prabotulinumtoxinA-xvfs (PRA 20) or onabotulinumtoxinA (ONA 20). Both 20-U controls were administered as 5 injections of 4â U/0.1â mL. Efficacy and safety were assessed on days 2, 7 (by telephone), 30, and every 30 days thereafter up to 365 days or until the patient had returned to baseline. The primary effectiveness endpoint was the duration of effect (estimated by Kaplan-Meier analysis), defined as the number of days from treatment day (baseline) to the day that glabellar line severity at maximum frown by investigator assessment returned to the baseline value.RESULTS:
Patients had a mean age of 47 years (20-72 years); 69.5% had severe glabellar lines at baseline. Of the 36 adverse events, 32 (88.9%) were mild and 4 (11.1%) were moderate in severity; none were serious. The median durations of effect were estimated to be 183, 149, and 148 days for PRA 40-, PRA 20-, and ONA 20-treated patients, respectively.CONCLUSIONS:
In this phase 2 pilot study, 40â U prabotulinumtoxinA-xvfs was observed to be safe and had a duration of 6 months.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Envelhecimento da Pele
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Toxinas Botulínicas Tipo A
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Testa
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article