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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04579419
Other study ID # RC19/371
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 9, 2019
Est. completion date August 9, 2020

Study information

Verified date October 2020
Source King Abdulaziz Medical City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 9, 2020
Est. primary completion date August 9, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sodium Bicarbonate
Botulinum Toxin diluted in Sodium Bicarbonate
Normal Saline
0.9 NaCl

Locations

Country Name City State
Saudi Arabia King Abdulaziz Medical City Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Abdulaziz Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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