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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2021-12-15

Brief Summary

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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.

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Detailed Description

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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

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Glabellar Frown Lines Rhytides Wrinkle Facial Expression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Split-Face: comparing two neurotoxin injection techniques, conventional palpation vs. EMG-guided injection.

Follow up using EMG analysis and Glabellar Merz Scales

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Palpation-guided

injected with the Palpation Method of neurotoxin adminstration

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

Botulinum toxin type A injection into the Corrugator Supercilii muscle

EMG-guided

injected with the EMG-guided Method of neurotoxin adminstration

Group Type EXPERIMENTAL

Electromyography-Needle Intramuscular Drug guidance

Intervention Type DEVICE

EMG-guided needle neurotoxin injection

Botulinum toxin type A

Intervention Type DRUG

Botulinum toxin type A injection into the Corrugator Supercilii muscle

Interventions

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Electromyography-Needle Intramuscular Drug guidance

EMG-guided needle neurotoxin injection

Intervention Type DEVICE

Botulinum toxin type A

Botulinum toxin type A injection into the Corrugator Supercilii muscle

Intervention Type DRUG

Other Intervention Names

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Electromyography-guided injection Botulinum neurotoxin BoNT - A BTX - A

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes