Is Cold Storage Still a Must? Evaluating Room-Temperature OnabotulinumtoxinA for Glabellar Lines Treatment

Ruth Yimna Del Socorro Blanco Rodriguez, Giancarlo De La Torre Canales, César Nunes Giracca, Thaís Caroline Schwartz Saldanha Vaz, Gislaine Paulovski, Lucas Alexandre de Sousa Mendes, Jairo Matozinho Cordeiro, Fábio Seigi Murakami, Mariana Barbosa Câmara-Souza

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Article numbere70554
JournalJournal of Cosmetic Dermatology
Volume24
Issue number11
DOIs
Publication statusPublished - Nov 2025

Keywords

  • botulinum toxins type A
  • reconstitution
  • temperature

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