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

NCT04579419 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-08

No results posted yet for this study

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

DRUG

Sodium Bicarbonate

Botulinum Toxin diluted in Sodium Bicarbonate

DRUG

Normal Saline

0.9 NaCl

Sponsors & Collaborators

  • King Abdulaziz Medical City

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-09
Primary Completion
2020-08-09
Completion
2020-08-09

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04579419 on ClinicalTrials.gov