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

Mohamed Hayder Oleish Salih

Status: Completed

Conditions: Glabellar Frown Lines; Facial Expression; Wrinkle; Rhytides

Treatments: Device: Electromyography-Needle Intramuscular Drug guidance; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT05517538

0106811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Palpation-guided

Experimental group

Description:

injected with the Palpation Method of neurotoxin adminstration

Treatment:

Drug: Botulinum toxin type A

EMG-guided

Experimental group

Description:

injected with the EMG-guided Method of neurotoxin adminstration

Treatment:

Drug: Botulinum toxin type A

Device: Electromyography-Needle Intramuscular Drug guidance