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

August 24, 2022 updated by: Mohamed Hayder Oleish Salih

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Palpation-guided
injected with the Palpation Method of neurotoxin adminstration
Drug: Botulinum toxin type A
Botulinum toxin type A injection into the Corrugator Supercilii muscle
Other Names:
  • Botulinum neurotoxin
  • BoNT - A
  • BTX - A
EXPERIMENTAL: EMG-guided
injected with the EMG-guided Method of neurotoxin adminstration
Drug: Botulinum toxin type A
Botulinum toxin type A injection into the Corrugator Supercilii muscle
Other Names:
  • Botulinum neurotoxin
  • BoNT - A
  • BTX - A
Device: Electromyography-Needle Intramuscular Drug guidance
EMG-guided needle neurotoxin injection
Other Names:
  • Electromyography-guided injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interferance pattern Envelop amplitude (IPEA)
Time Frame: 3 months
difference between + and - spikes in the EMG waveform [microvolt]
3 months
Muscle activity percentage (MAp)
Time Frame: 3 months
percentage difference between the IPEA at follow up and base line [%]
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glabellar Merz scales
Time Frame: 3 months
Glabellar Merz scales : Dunamic and static [0-4]
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Hayder Oleish Salih

Investigators

  • Principal Investigator: Mohamed H Oleish, MB BCh, University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 9, 2021

Primary Completion (ACTUAL)

December 2, 2021

Study Completion (ACTUAL)

December 15, 2021

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (ACTUAL)

August 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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