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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05517538
Enrollment
15
Registered
2022-08-26
Start date
2021-08-09
Completion date
2021-12-15
Last updated
2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Expression, Glabellar Frown Lines, Rhytides, Wrinkle

Keywords

Botulinum Toxin, EMG-Guided Botulimun toxin injection, Cosmetic Botulinum toxin, Glabellar Merz Scale

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.

Interventions

DEVICEElectromyography-Needle Intramuscular Drug guidance

EMG-guided needle neurotoxin injection

DRUGBotulinum toxin type A

Botulinum toxin type A injection into the Corrugator Supercilii muscle

Sponsors

Mohamed Hayder Oleish Salih
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Glabellar Merz scales3 monthsGlabellar Merz scales : Dunamic and static \[0-4\]

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026