Is Cold Storage Still a Must? Evaluating Room-Temperature OnabotulinumtoxinA for Glabellar Lines Treatment
- PMID: 41252535
- PMCID: PMC12626392
- DOI: 10.1111/jocd.70554
Is Cold Storage Still a Must? Evaluating Room-Temperature OnabotulinumtoxinA for Glabellar Lines Treatment
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.
Keywords: botulinum toxins type A; reconstitution; temperature.
© 2025 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.
Conflict of interest statement
The authors declare no conflicts of interest.
References
-
- Gostimir M., Liou V., and Yoon M. K., “Safety of Botulinum Toxin A Injections for Facial Rejuvenation: A Meta‐Analysis of 9,669 Patients,” Ophthalmic Plastic and Reconstructive Surgery 39, no. 1 (2023): 13–25. - PubMed
-
- International Society of Aesthetic Plastic Surgery , “ISAPS Internatiional Survey on Aesthetic/Cosmetic Procedures Performed in 2024 [Internet],” [citado 10 de setembro de 2025], Disponível em: https://www.isaps.org/media/oogpzodr/isaps‐global‐survey_2024.pdf.
-
- Allergan , “BOTOX,” Journal of the American Academy of Dermatology 55, no. 2 (2006): 272–275. - PubMed
-
- Ipsen Biopharm Ltd ., “DYSPORT [Internet],” Ash Road North, Reino Unido; [citado 10 de setembro de 2025], Disponível em: https://www.ipsen.com/websites/ipsen_com_v2/wp‐content/uploads/sites/22/....
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Medical
