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Completed

NCT Number: NCT04579419

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

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.

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Key information

Conditions

Wrinkle

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium bicarbonate

Drug

Botulinum Toxin diluted in Sodium Bicarbonate

normal saline

Drug

0.9 NaCl

Primary outcomes

  1. Injection site pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz Medical City

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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