Brow LiftingPhase 4NCT02942303
The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial
A Phase 4 study testing Dysport, lateral orbicularis injection and Lateral orbicularis + corrugator injection in people with Brow Lifting, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
The purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales. Read more about this study
- Who is it for?
- Ages 28 to 50 years, women only
- Conditions the study is for
- Brow Lifting
- What is being tested?
- Dysport, lateral orbicularis injection and Lateral orbicularis + corrugator injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2016to May 2017
- Phase
- Phase 4
- 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 28 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Consecutive 30 female patients presenting to our clinic for brow lifting with botulinum toxin will be randomized to receive one of the two injection techniques
Who cannot join
- Patients with previous periorbital/forehead surgery
- Patients who plucked the upper eyebrow margin
- Patients with eyebrow tatoos
- Patients with upper face botulinum toxin injection in the past 12 months
- Patients with resorbable upper face fillers injection in the past 12 months
- Patients with previous permanent upper face fillers injection
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- Pregnant patients
- Lactating patients
- Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
- Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
- Patients with sensitivity to botulinum toxin or human albumin
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Hotel Dieu De France
Beirut, Aschrafieh, 00961
samer jabbour, M.D., 009613416234, samermed@gmail.com
About this study
The purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales.
- Conditions
- Brow Lifting
- Being tested
- Dysport, lateral orbicularis injection, Lateral orbicularis + corrugator injection
- Keywords
- Botulinum Toxin, Rejuvenation, Brow lift, Eyebrow.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DysportDrug
Also called abobotulinumtoxineA
lateral orbicularis injectionProcedure or surgery
Lateral orbicularis + corrugator injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Technique 1: Lateral orbicularis injections | Active comparator | 5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. Receives: Drug: Dysport; Procedure: lateral orbicularis injection |
| 2. Technique 2: Lateral orbicularis and Corrugator injections | Active comparator | 5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. In addition, 2 injections will be placed into the corrugator at the medial brow Receives: Drug: Dysport; Procedure: Lateral orbicularis + corrugator injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective assessment
Objective assessment will be done on anteroposterior views of pre-and-post injection photographs. The mid pupillary line will be drawn and the eyebrow vertical height will be measured from this line to the upper border of the brow at seven horizontal points: the most medial aspect of the eyebrow, medial canthus, medial limbus, mid pupil, lateral limbus, lateral sclera, and most lateral eyebrow.
Measured: 15 days post treatment
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction will be determined by a questionnaire completed at 15 days post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow:
- Very Satisfied
- Satisfied
- Dissatisfied
- Very Dissatisfied.
Measured: 15 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brow LiftingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samer jabbour, St Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942303
- Sponsor's protocol ID
- USJ-03
- Status last verified
- May 2017
- First submitted
- 20 Oct 2016
- Last updated
- 15 May 2017
- Results posted
- No
Publications
El-Khoury JS, Jabbour SF, Awaida CJ, Rayess YA, Kechichian EG, Nasr MW. The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial. Plast Reconstr Surg. 2018 Jan;141(1):75-78. doi: 10.1097/PRS.0000000000003919.
PubMed 29280866
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02942303
- Acronym / sponsor ID
- USJ-03
- Conditions
- Brow Lifting
- Keywords
- Botulinum Toxin, Rejuvenation, Brow lift, Eyebrow.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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 purpose of this study is to describe three safe and reproducible techniques for brow lifting using botulinum toxin. It will also describe the effect of 2 techniques on the eyebrow shape using quantitative, objective measurements and satisfaction scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technique 1: Lateral orbicularis injections | Active comparator | Drug: Dysport, Procedure: lateral orbicularis injection5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. |
| 2. Technique 2: Lateral orbicularis and Corrugator injections | Active comparator | Drug: Dysport, Procedure: Lateral orbicularis + corrugator injection5 equally spaced injections will be placed intramuscularly into the orbicularis under the lateral eyebrow starting lateral to the level of the lateral limbus and extending to the level of the inferior orbital rim. In addition, 2 injections will be placed into the corrugator at the medial brow |
Who may qualify
- Ages
- 28 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Consecutive 30 female patients presenting to our clinic for brow lifting with botulinum toxin will be randomized to receive one of the two injection techniques
Key exclusion criteria (11 listed)
- Patients with previous periorbital/forehead surgery
- Patients who plucked the upper eyebrow margin
- Patients with eyebrow tatoos
- Patients with upper face botulinum toxin injection in the past 12 months
- Patients with resorbable upper face fillers injection in the past 12 months
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 |
|---|---|---|
| DysportAlso: abobotulinumtoxineA | Drug | 2. Technique 2: Lateral orbicularis and Corrugator injections, Technique 1: Lateral orbicularis injections |
| lateral orbicularis injection | Procedure or surgery | Technique 1: Lateral orbicularis injections |
| Lateral orbicularis + corrugator injection | Procedure or surgery | 2. Technique 2: Lateral orbicularis and Corrugator injections |
Primary outcome
Objective assessment
Time frame: 15 days post treatment
Objective assessment will be done on anteroposterior views of pre-and-post injection photographs. The mid pupillary line will be drawn and the eyebrow vertical height will be measured from this line to the upper border of the brow at seven horizontal points: the most medial aspect of the eyebrow, medial canthus, medial limbus, mid pupil, lateral limbus, lateral sclera, and most lateral eyebrow.
1 secondary outcome
Patient satisfaction
Time frame: 15 days post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Derived from this study: PubMed 29280866El-Khoury JS, Jabbour SF, Awaida CJ, Rayess YA, Kechichian EG, Nasr MW. The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial. Plast Reconstr Surg. 2018 Jan;141(1):75-78. doi: 10.1097/PRS.0000000000003919.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dysport, lateral orbicularis injection and Lateral orbicularis + corrugator injection in people with Brow Lifting, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 May 2017. 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 Lebanon. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective assessment (time frame: 15 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942303, which also lists 1 linked publication.
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 15 May 2017.