NCT04579419

Injection Site Pain Botulinum Toxin Reconstituted in NS With and Without Sodium Bicarbonate

Injection Site Pain, Onset and Duration of Action of Botulinum Toxin Reconstituted in Normal Saline With and Without Sodium Bicarbonate; A Prospective, Single Center, Randomized, Double-Blind Interventional Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: King Abdulaziz Medical City · Other Government
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

This study was designed to investigate the effects of botulinum toxin type A injections diluted with the mixture of sodium bicarbonate (SB) and normal saline (NS) on pain reduction, onset of action and duration of action. This is a prospective, randomized, double-blind clinical study, which included 30 female patients (age\>25). The patients were randomized to receive botulinum toxin (BT) injections diluted with NS and SB on one side of the face and saline control injections on the other side. Pain severity was assessed using visual analogue scale. The onset and duration of action were recorded according to the patients' subjective opinions after 1 week and 3 months, respectively. The study was approved with an IRB (Institutional Review Board) number of RC19/371.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DRUG	Sodium Bicarbonate	Botulinum Toxin diluted in Sodium Bicarbonate
DRUG	Normal Saline	0.9 NaCl

Timeline

• Start date: 2019-11-09
• Primary completion: 2020-08-09
• Completion: 2020-08-09
• First posted: 2020-10-08
• Last updated: 2020-10-08

Locations

1 site across 1 country: Saudi Arabia