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

Not Applicable

Completed

• Conditions: Glabellar Frown Lines; Rhytides; Facial Expression; Wrinkle
• Interventions: Device: Electromyography-Needle Intramuscular Drug guidance; Drug: Botulinum toxin type A

• Registration Number: NCT05517538
• Lead Sponsor: Mohamed Hayder Oleish Salih

Brief 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.

Study Timeline

• Study Start: 2021-08-09
• Primary Completion: 2021-12-02
• Study Completion: 2021-12-15
• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-24
• Last Update Submitted: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Consent.
• Patients within age range of 25 - 60 years.
• Visible corrugator muscle rhytids when frowning by examination.

Exclusion Criteria

• Patients with no, or minimal wrinkles on the studied area.
• Previous use of botulinum toxin in the previous 6 months.
• Patients on regular or very occasional antispasmodics.
• Patients with any neuromuscular disorders, infections or skin problems at the injection site.
• Patients with any known neurological disease.
• Patients who undergone surgery involving the glabellar area.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMG-guided	Electromyography-Needle Intramuscular Drug guidance	injected with the EMG-guided Method of neurotoxin adminstration
Palpation-guided	Botulinum toxin type A	injected with the Palpation Method of neurotoxin adminstration
EMG-guided	Botulinum toxin type A	injected with the EMG-guided Method of neurotoxin adminstration

Primary Outcome Measures

Name	Time	Method
Interferance pattern Envelop amplitude (IPEA)	3 months	difference between + and - spikes in the EMG waveform \[microvolt\]
Muscle activity percentage (MAp)	3 months	percentage difference between the IPEA at follow up and base line \[%\]

Secondary Outcome Measures

Name	Time	Method
Glabellar Merz scales	3 months	Glabellar Merz scales : Dunamic and static \[0-4\]

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Alexandria, Egypt