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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04579419

Enrollment

Registered

2020-10-08

Start date

2019-11-09

Completion date

2020-08-09

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrinkle

Brief 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.

Interventions

DRUGSodium Bicarbonate

Botulinum Toxin diluted in Sodium Bicarbonate

DRUGNormal Saline

0.9 NaCl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Any female patient who is in good health and has moderate dynamic forehead and glabellar wrinkles.

Exclusion criteria

* • Patients \<25 years old * Presence of neuromuscular disease or intake of drugs affecting muscle tone. * Any active infection in the treatment area. * Patients receiving anticoagulation or had a diagnosis of bleeding disorders. * Any patient who had undergone the following treatments to the forehead area in the past 6 months: botulinum toxin injections, ablative laser procedures, radiofrequency device treatments, ultrasound device treatments, or medium to deep chemical peels. * Any patient who had temporary soft-tissue augmentation material to the forehead area in the past 12 months, semi permanent soft-tissue augmentation material in the past 2 years, or permanent soft-tissue augmentation material at any point in the past. * Any patient with prior facial cosmetic surgical procedures such as eyebrow-lifts, blepharoplasties, and rhytidectomies.

Design outcomes

Primary

Measure	Time frame	Description
Injection site pain	Immediately after the injections	Pain severity was assessed using Visual Analogue Scale (VAS).The VAS score ranged from 0 to 10, with 0 representing no pain and 10 the greatest imaginable pain. Higher scores indicated worse outcome.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026