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Completed

NCT Number: NCT05517538

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

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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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electromyography-Needle Intramuscular Drug guidance

Device

EMG-guided needle neurotoxin injection

Other names: Electromyography-guided injection

Botulinum Toxin Type A

Drug

Botulinum toxin type A injection into the Corrugator Supercilii muscle

Other names: Botulinum neurotoxin, BoNT - A, BTX - A

Primary outcomes

  1. Interferance pattern Envelop amplitude (IPEA)

    Time frame: 3 months

    difference between + and - spikes in the EMG waveform [microvolt]

  2. Muscle activity percentage (MAp)

    Time frame: 3 months

    percentage difference between the IPEA at follow up and base line [%]

Secondary outcomes

  1. Glabellar Merz scales

    Time frame: 3 months

    Glabellar Merz scales : Dunamic and static [0-4]

Sponsors and collaborators

Lead sponsor

Mohamed Hayder Oleish Salih

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2022
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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