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

Study Overview
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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.

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.

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

Conditions
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Glabellar Frown Lines, Rhytides, Wrinkle, Facial Expression

Intervention / Treatment
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* Device: Electromyography-Needle Intramuscular Drug guidance
* Drug: Botulinum toxin type A


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-Face: comparing two neurotoxin injection techniques, conventional palpation vs. EMG-guided injection. Follow up using EMG analysis and Glabellar Merz Scales
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palpation-guided<br>injected with the Palpation Method of neurotoxin adminstration | Drug: Botulinum toxin type A<br>* Botulinum toxin type A injection into the Corrugator Supercilii muscle<br>* Other names: BTX - A;|
| Experimental: EMG-guided<br>injected with the EMG-guided Method of neurotoxin adminstration | Device: Electromyography-Needle Intramuscular Drug guidance<br>* EMG-guided needle neurotoxin injection<br>* Other names: Electromyography-guided injection;Drug: Botulinum toxin type A<br>* Botulinum toxin type A injection into the Corrugator Supercilii muscle<br>* Other names: BTX - A;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glabellar Merz scales | Glabellar Merz scales : Dunamic and static [0-4] | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmetic Botulinum toxin, Glabellar Merz Scale, Botulinum Toxin, EMG-Guided Botulimun toxin injection