Clinical trial NCT05517538: Split-face Study: Cosmetic Botulinum Toxin Type A Injection Under Electromyography-guidance Versus Conventional Palpation Technique
Official title: COMPARISON BETWEEN THE EFFICACY AND DURATION OF COSMETIC BOTULINUM TOXIN TYPE A INJECTION WITH AND WITHOUT ELECTROMYOGRAPHIC GUIDANCE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glabellar Frown Lines
Rhytides
Wrinkle
Facial Expression
Keywords: Botulinum Toxin
EMG-Guided Botulimun toxin injection
Cosmetic Botulinum toxin
Glabellar Merz Scale
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-Face: comparing two neurotoxin injection techniques, conventional palpation vs. EMG-guided injection.

Follow up using EMG analysis and Glabellar Merz Scales
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Interferance pattern Envelop amplitude (IPEA)
timeFrame: 3 months
measure: Muscle activity percentage (MAp)
timeFrame: 3 months
Secondary outcomes:
measure: Glabellar Merz scales
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: University of Alexandria
name: Mohamed H Oleish, MB BCh
role: PRINCIPAL_INVESTIGATOR
References: