Blind Multicenter Study of the Efficacy and Safety of Injections of a Commercial Preparation of Botulinum Toxin Type A Reconstituted up to 15 Days Before Injection

Abstract

The results confirm the possibility of injecting 500 U of BT-A up to 15 days after its reconstitution safely and without loss of efficacy.

Recommendations and current practices for the reconstitution and storage of botulinum toxin type A

“…After cold storage of reconstituted BT-A for 2 weeks, the toxin has been shown to retain its efficacy and time of onset in the treatment of lateral periorbital rhytids 11 (crow's feet), horizontal forehead rhytids, 13 and glabellar rhytids. 12 The follow-up periods in these studies ranged from 3 to 4 months.…”

“…In a study with one of the longest periods of refrigerator storage, no bacterial contamination was identified after 10 months. 12 Together, these studies provide solid evidence that BT-A reconstitution and storage for periods significantly longer than suggested by the manufacturers is both safe and clinically effective, and commonplace in clinical practice. Our recommendation for the storage and use of BT-A for 2 weeks after reconstitution is based on the numerous studies demonstrating preserved toxin efficacy after a 2-week storage period.…”

“…No evidence of bacterial contamination has been reported after cold storage of reconstituted BT-A for periods of 5 to 7 days, 16 7 weeks, 17 12 weeks, 7 and 10 months. 12 Menon and Murray 16 did not find any microbial growth in vials of reconstituted BT-A after 4 hours of exposure to room temperature followed by refrigerator storage for 5 to 7 days. Alam et al 17 found no contamination in vials of reconstituted BT-A after refrigerator storage and serial re-extractions over 7 weeks.…”

Gummy Smile Treatment With Botulinum Toxin and Review of Literature- A Case Report

“…However, in some studies it has shown that toxin's efficacy remains same until 15 days after reconstitution and no bacterial contamination occurs. 28 Despite of some adverse effects and reversibility of BTX-A via regeneration of nerve-muscle complex and SNAP-25 proteins, BTX-A injections seems to be the least invasive treatment option for gummy smile cases.…”

The use of botulinum toxin type A in cosmetic facial procedures

“…This recommendation is for sterility and efficacy purposes. Recent studies have shown that toxin efficacy remains the same until 15 days after reconstitution, and bacterial contamination does not take place 20 .…”