Clinical Trials Directory

Trials / Completed

CompletedNCT05517538

Split-face Study: Cosmetic Botulinum Toxin Type A Injection Under Electromyography-guidance Versus Conventional Palpation Technique

COMPARISON BETWEEN THE EFFICACY AND DURATION OF COSMETIC BOTULINUM TOXIN TYPE A INJECTION WITH AND WITHOUT ELECTROMYOGRAPHIC GUIDANCE

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Mohamed Hayder Oleish Salih · Academic / Other
Sex
All
Age
25 Years – 60 Years
Healthy volunteers
Accepted

Summary

The aim of this study was to compare between the conventional palpation method of botulinum toxin type A injection and the electromyography-guided method using clinical parameters and electromyography analysis.

Detailed description

The study was conducted on 15 healthy-looking female subjects with visible glabellar rhytids when frowning. All participants were recruited from the outpatient clinic of Dermatology Department, Main University Hospital, Faculty of Medicine, Alexandria University. The mean age was 46.27 ± 6.31 with a range from 33 to 59 years. All 15 subjects completed the study. Each subject provided a right and left corrugator supercilii muscles to the study. Each muscle was divided into a body and a tail, each part injected separately (n=60). Neurotoxin injection into the corrugator body and tail by palpation method on one side and under EMG-guidance on the other. Photographs were taken both at rest, and while frowning at each visit: pre-operatively, after 2 weeks and after 3 months. Clinical grading according to static and dynamic Merz glabellar frown line scales and EMG analysis was done at each visit: pre-operatively, after 2 weeks and after 3 months.

Conditions

Interventions

TypeNameDescription
DEVICEElectromyography-Needle Intramuscular Drug guidanceEMG-guided needle neurotoxin injection
DRUGBotulinum toxin type ABotulinum toxin type A injection into the Corrugator Supercilii muscle

Timeline

Start date
2021-08-09
Primary completion
2021-12-02
Completion
2021-12-15
First posted
2022-08-26
Last updated
2022-08-26

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05517538. Inclusion in this directory is not an endorsement.