Glabellar Frown LinesNCT05517538
Split-face Study: Cosmetic Botulinum Toxin Type A Injection Under Electromyography-guidance Versus Conventional Palpation Technique
A study testing Electromyography-Needle Intramuscular Drug guidance and Botulinum toxin type A in people with Glabellar Frown Lines and Rhytides, run by Mohamed Hayder Oleish Salih at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines, Rhytides, Wrinkle
- What is being tested?
- Electromyography-Needle Intramuscular Drug guidance and Botulinum toxin type A
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Aug 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consent.
- Patients within age range of 25 - 60 years.
- Visible corrugator muscle rhytids when frowning by examination.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glabellar Frown Lines, Rhytides, Wrinkle, Facial Expression
- Being tested
- Electromyography-Needle Intramuscular Drug guidance, Botulinum toxin type A
- Keywords
- Botulinum Toxin, EMG-Guided Botulimun toxin injection, Cosmetic Botulinum toxin, Glabellar Merz Scale
- Medical subject headings
- Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography-Needle Intramuscular Drug guidanceDevice
Also called Electromyography-guided injection
EMG-guided needle neurotoxin injection
Botulinum toxin type ADrug
Also called Botulinum neurotoxin, BoNT - A, BTX - A
Botulinum toxin type A injection into the Corrugator Supercilii muscle
| Study group | Role | What they receive |
|---|---|---|
| Palpation-guided | Experimental | injected with the Palpation Method of neurotoxin adminstration Receives: Drug: Botulinum toxin type A |
| EMG-guided | Experimental | injected with the EMG-guided Method of neurotoxin adminstration Receives: Device: Electromyography-Needle Intramuscular Drug guidance; Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interferance pattern Envelop amplitude (IPEA)
difference between + and - spikes in the EMG waveform [microvolt]
Measured: 3 months
Muscle activity percentage (MAp)
percentage difference between the IPEA at follow up and base line [%]
Measured: 3 months
Secondary outcomes (1)
Glabellar Merz scales
Glabellar Merz scales : Dunamic and static [0-4]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start9 Aug 2021
- Primary completion2 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Split-Face: comparing two neurotoxin injection techniques, conventional palpation vs. EMG-guided injection. Follow up using EMG analysis and Glabellar Merz Scales
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Hayder Oleish Salih
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Hayder Oleish Salih, Alexandria University
- Investigators
- Mohamed H Oleish, MB BCh, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517538
- Sponsor's protocol ID
- 0106811
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN THE EFFICACY AND DURATION OF COSMETIC BOTULINUM TOXIN TYPE A INJECTION WITH AND WITHOUT ELECTROMYOGRAPHIC GUIDANCE
- ClinicalTrials.gov ID
- NCT05517538
- Acronym / sponsor ID
- 0106811
- Conditions
- Glabellar Frown Lines, Rhytides, Wrinkle, Facial Expression
- Keywords
- Botulinum Toxin, EMG-Guided Botulimun toxin injection, Cosmetic Botulinum toxin, Glabellar Merz Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mohamed Hayder Oleish SalihUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-Face: comparing two neurotoxin injection techniques, conventional palpation vs. EMG-guided injection. Follow up using EMG analysis and Glabellar Merz Scales
| Arm | Type | Receives |
|---|---|---|
| Palpation-guided | Experimental | Drug: Botulinum toxin type Ainjected with the Palpation Method of neurotoxin adminstration |
| EMG-guided | Experimental | Device: Electromyography-Needle Intramuscular Drug guidance, Drug: Botulinum toxin type Ainjected with the EMG-guided Method of neurotoxin adminstration |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Consent.
- Patients within age range of 25 - 60 years.
- Visible corrugator muscle rhytids when frowning by examination.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyography-Needle Intramuscular Drug guidanceAlso: Electromyography-guided injectionEMG-guided needle neurotoxin injection | Device | EMG-guided |
| Botulinum toxin type AAlso: Botulinum neurotoxin, BoNT - A, BTX - ABotulinum toxin type A injection into the Corrugator Supercilii muscle | Drug | EMG-guided, Palpation-guided |
Primary outcome
Interferance pattern Envelop amplitude (IPEA)
Time frame: 3 months
difference between + and - spikes in the EMG waveform [microvolt]
Muscle activity percentage (MAp)
Time frame: 3 months
percentage difference between the IPEA at follow up and base line [%]
1 secondary outcome
Glabellar Merz scales
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Glabellar Frown Lines
RecruitingPhase 4
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Wrinkle, Glabellar Frown Lines
Active, not recruitingPhase 1
Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines
Glabellar Frown Lines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed H Oleish, MB BCh principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography-Needle Intramuscular Drug guidance and Botulinum toxin type A in people with Glabellar Frown Lines and Rhytides, run by Mohamed Hayder Oleish Salih at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interferance pattern Envelop amplitude (IPEA) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.