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

NCT04579419 | Completed Phase 3 DMC

• 1 other identifier: RC19/371
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Injection site pain

  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.

  Immediately after the injections

Study Arms (2)

Sodium Bicarbonate

EXPERIMENTAL

Drug: Sodium Bicarbonate

Normal Saline

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

Sodium Bicarbonate DRUG

Botulinum Toxin diluted in Sodium Bicarbonate

Sodium Bicarbonate

Normal Saline DRUG

0.9 NaCl

Normal Saline

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz Medical City: lead

Study Sites (1)

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Location

MeSH Terms

Interventions

Sodium Bicarbonate; Saline Solution

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Intern

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: November 9, 2019
• Primary Completion: August 9, 2020
• Study Completion: August 9, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

SA (1)