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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517538
• Other study ID #: 0106811
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: August 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 15, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Expression
• Glabellar Frown Lines
• Rhytides
• Wrinkle

Intervention

Device:
• Electromyography-Needle Intramuscular Drug guidance
EMG-guided needle neurotoxin injection

Drug:
• Botulinum toxin type A
Botulinum toxin type A injection into the Corrugator Supercilii muscle

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Hayder Oleish Salih

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interferance pattern Envelop amplitude (IPEA)	difference between + and - spikes in the EMG waveform [microvolt]	3 months
Primary	Muscle activity percentage (MAp)	percentage difference between the IPEA at follow up and base line [%]	3 months
Secondary	Glabellar Merz scales	Glabellar Merz scales : Dunamic and static [0-4]	3 months