Journal of cosmetic dermatology · 2025
Is Cold Storage Still a Must? Evaluating Room-Temperature OnabotulinumtoxinA for Glabellar Lines Treatment.
СтатьяНазвание и аннотация: Перевод в очереди
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Rodriguez Ruth Yimna Del Socorro Blanco, De La Torre Canales Giancarlo, Giracca César Nunes, Vaz Thaís Caroline Schwartz Saldanha, Paulovski Gislaine, Mendes Lucas Alexandre de Sousa, Cordeiro Jairo Matozinho, Murakami Fábio Seigi, Câmara-Souza Mariana Barbosa
Аннотация
BACKGROUND: New botulinum toxin type A (BoNT-A) formulations eliminated cold-chain storage before reconstitution. Nonetheless, concerns remain about BoNT-A properties when stored at room temperature after reconstitution.
AIM: This study aimed to evaluate the sterility and effectiveness of BoNT-A storage at room temperature in glabellar wrinkles.
METHODS: BoNT-A (Allergan Botox, Brazil) was reconstituted and maintained in a stove at 37°C for 60 days and then tested for sterility according to the Pharmacopeia guidelines. Then, sixty patients aged 25-60 years were divided into two groups: Group 1 (G1) received BoNT-A immediately after reconstitution, and Group 2 (G2) received BoNT-A after 7 days at room temperature. Participants were assessed for wrinkle severity using the Merz Scale, satisfaction with treatment using the Face-Q scale, and muscle activity by electromyography. Data were collected before injections and after 15, 30, 60, and 90 days.
RESULTS: Absence of turbidity evidenced no microbial growth in all periods analyzed. Both groups showed significant reductions in glabellar contraction (p < 0.001), wrinkle severity (p < 0.05), and improved satisfaction. G1 presented lower wrinkle severity, while G2 reported higher satisfaction (p < 0.05).
CONCLUSION: Room temperature and longer storage periods may not affect OnabotulinumtoxinA sterility and clinical results.
AIM: This study aimed to evaluate the sterility and effectiveness of BoNT-A storage at room temperature in glabellar wrinkles.
METHODS: BoNT-A (Allergan Botox, Brazil) was reconstituted and maintained in a stove at 37°C for 60 days and then tested for sterility according to the Pharmacopeia guidelines. Then, sixty patients aged 25-60 years were divided into two groups: Group 1 (G1) received BoNT-A immediately after reconstitution, and Group 2 (G2) received BoNT-A after 7 days at room temperature. Participants were assessed for wrinkle severity using the Merz Scale, satisfaction with treatment using the Face-Q scale, and muscle activity by electromyography. Data were collected before injections and after 15, 30, 60, and 90 days.
RESULTS: Absence of turbidity evidenced no microbial growth in all periods analyzed. Both groups showed significant reductions in glabellar contraction (p < 0.001), wrinkle severity (p < 0.05), and improved satisfaction. G1 presented lower wrinkle severity, while G2 reported higher satisfaction (p < 0.05).
CONCLUSION: Room temperature and longer storage periods may not affect OnabotulinumtoxinA sterility and clinical results.