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

NCT05517538 | Completed

• 1 other identifier: 0106811
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Glabellar Frown Lines; Rhytides; Wrinkle; Facial Expression

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Glabellar Merz scales

  3 months

Study Arms (2)

Palpation-guided

EXPERIMENTAL

injected with the Palpation Method of neurotoxin adminstration

Drug: Botulinum toxin type A

EMG-guided

EXPERIMENTAL

injected with the EMG-guided Method of neurotoxin adminstration

Device: Electromyography-Needle Intramuscular Drug guidance; Drug: Botulinum toxin type A

Interventions

Electromyography-Needle Intramuscular Drug guidance DEVICE

EMG-guided needle neurotoxin injection

Also known as: Electromyography-guided injection

EMG-guided

Botulinum toxin type A DRUG

Botulinum toxin type A injection into the Corrugator Supercilii muscle

Also known as: Botulinum neurotoxin, BoNT - A, BTX - A

EMG-guided; Palpation-guided

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Consent.
• Patients within age range of 25 - 60 years.
• Visible corrugator muscle rhytids when frowning by examination.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Hayder Oleish Salih: lead

Study Sites (1)

Faculty of medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Facial Expression

Interventions

Botulinum Toxins, Type A; Botulinum Toxins; incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Mohamed H Oleish, MB BCh

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Masters Student

Model Details: Split-Face: comparing two neurotoxin injection techniques, conventional palpation vs. EMG-guided injection. Follow up using EMG analysis and Glabellar Merz Scales

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 26, 2022
• Study Start: August 9, 2021
• Primary Completion: December 2, 2021
• Study Completion: December 15, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)