BrowliftPhase 4NCT03186001
Frontalis Botulinum Toxin
A Phase 4 study testing Abobotulinum toxin A in people with Browlift, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
The botulinum toxin was first identified in the late 19th century(1). With its 40 different subtype this toxin is produced mainly by the gram positive anaerobic bacteria Clostridium Botulinum(2). Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Browlift
- What is being tested?
- Abobotulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2017to 1 Aug 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- 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
- 30 Years to 60 Years
- Female
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
Show all 11Show fewer
- 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
Saint Joseph University
Beirut, 0000
joseph el khoury, M.D., 00961 70745258, drjosephelkhoury@gmail.com
About this study
Official title: The Impact of Botulinum Toxin Injection in the Frontalis on Brow Height and Morphology: A Randomized Trial
The botulinum toxin was first identified in the late 19th century(1). With its 40 different subtype this toxin is produced mainly by the gram positive anaerobic bacteria Clostridium Botulinum(2). This neurotoxin has great affinity to the neuro muscular junction preventing neurotransmitter release in the synaptic space of acetylcholine(3). The first clinical use was reported by Alan Scott in 1980(4). The most commonly used subtype is toxin A commercially found as BOTOX (onabotulinumtoxinA, Allergan, approved by FDA in 1989), Dysport (abobotulinumtoxinA, Medicis, approved by FDA in 2009) and Xeomin (incobotulinumtoxinA, Merz, approved by FDA in 2010). As for other commercial toxins botulinum neurotoxin serotype B product (MYOBLOC™). Neurotoxin Blast generally 12-15 weeks compared to 3-6 month for neurotoxin A. the FDA approved its use for strabismus in 1989(5), blepharospasm and hemifacial spasm in 1990(6,7), cervical dystonia in 2000(8), glabella in 2000, hyperhidrosis in 2004(9), chronic migrane and detrusor overactiviy in 2014. Other off-label uses have emerged like lanyngeal dysponia, chronic pain etc… (10). Multiple studies with a reduced number of patients have aimed to quantify the effect of botulinum toxin on brow higth. Some studies used injections only to the lateral part of the orbicularis,while others added a corrugator injection. We aimed in this study to compare a known techniques in brow lifting and associanting that with 2 frontalis injection techniques. The main objective is to evaluate the shape of the brow and the elevation in multiple brow landmarks before and after the injection and to see if the frontalis botulinum bloc causes brow ptosis
Read the detailed description
Botulinum toxin:
This toxin has been used clinically since 1989 with label (8) and off-label techniques(3).
This is a becoming a routine procedure for men and women with little side effects.
Brow lifting The ideal brow position is always an issue in plastic surgery(12). When face ages, the brow descends. Many approaches to a brow elevation are described in the literature. The first surgical approach is through a coronal incision(13), then came the temporal incision(14) and the direct approach(15), and finally the endoscopic approach(16). Non-surgical methods include radiofrequency(17), percutaneous sutures and botulinum toxin(11).
Standardized measure Anteroposterior pictures will be taken at rest pre and post injection. Using photoshop 7 brow landmarks will be measured to the midpupillary line.
- Conditions
- Browlift
- Being tested
- Abobotulinum toxin A
- Keywords
- frontalis, frontal line, glabellar line, botulinum toxin, abobotulinum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abobotulinum toxin ADrug
The purpose of this study is to describe two safe and reproducible techniques upper face botulinum toxin injection. It will also describe the effect of both techniques on the eyebrow shape and height using quantitative, objective measurements and subjective scales
| Study group | Role | What they receive |
|---|---|---|
| v shape | Experimental | Technique 1Lateral orbicularis and corrugator injections: 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 1cm apart into the corrugator starting at the medial brow and extending laterally. Then 5 equally spaced injections, in a V pattern will be placed in the frontalis. The first injection between the medial brows, 2 injection 1cm below the hairline at the level of the lateral canthus and one injection equidistant to medial and lateral injection. Receives: Drug: Abobotulinum toxin A |
| middle frontalis | Experimental | : Lateral orbicularis and corrugator injections: 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 1cm apart into the corrugator starting at the medial brow and extending laterally. Then 5 equally spaced injections, in a straight pattern will be placed in the frontalis. One injection in the middle of the forehead, one on the same level of the lateral canthus and one between them. Receives: Drug: Abobotulinum toxin A |
| high frontalis | Experimental | : Lateral orbicularis and corrugator injections: 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 1cm apart into the corrugator starting at the medial brow and extending laterally.Then 5 equally spaced injections, in a straight pattern 1 cm below the hairline will be placed in the frontalis. One injection in the middle of the forehead, one on the same level of the lateral canthus and one between them. Receives: Drug: Abobotulinum toxin A |
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, and medial limbus, mid pupil, lateral limbus, lateral canthus, and most lateral eyebrow.
Measured: 2 weeks
Secondary outcomes (5)
1-Investigators Global Aesthetic Improvement Scale
Improvement in Overall appearance of the upper face, as assessed by the 3 investigators (2 plastic surgeons and 1 dermatologist) using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on photographic assessment comparing post-treatment photos taken at day 15 post intervention to baseline photos (the lower eyelids and lower face will be cropped), to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows:
- Very Much Improved: optimal cosmetic results
- Much Improved: marked improvement in appearance from initial condition but not completely optimal
- Improved: obvious improvement in appearance from initial condition but additional treatments are advised
- No Change: the appearance is the same as the original condition
- Wose: the appearance is worse from the original condition
Measured: 2 weeks
2-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: 2 weeks
3-Brow Positioning Scale
subjective evaluation using a photonumeric validated scale for eye brow positioning (evaluated by 2 plastic surgeons and 1 dermatologist) using pre and post injection photographs (taken at day 15 and 30) as follow: 0-Youthful, refreshed look and high-arch eyebrow
- Medium-arch eyebrow
- Slight arch of the eyebrow
- Flat arch of the eyebrow, visibility of folds, and tired appearance
- Flat eyebrow with barely any arch, marked visibility of folds, and very tired appearance
Measured: 2 weeks
4-Forehead Lines Scale:
subjective evaluation using a photonumeric validated scale for forehead lines at rest (evaluated by 2 plastic surgeons and 1 dermatologist) using pre and post injection photographs (taken at day 15 and 30) as follow: 0-None
- Minimal
- Moderate
- Deep
- Extreme
Measured: 2 weeks
5-Glabellar Lines Scale
subjective evaluation using a photonumeric validated scale for glabella lines at rest (evaluated by 2 plastic surgeons and 1 dermatologist) using pre and post injection photographs (taken at day 15) as follow: 0-No glabella lines
- Mild glabella lines
- Moderate glabella lines
- Severe glabella lines
- Very severe glabella lines
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Aug 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 BrowliftStudies 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
- Participant, 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
- NCT03186001
- Sponsor's protocol ID
- USJ-06
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jabbour SF, Awaida CJ, ElKhoury JS, Rayess YA, Makhoul RB, Kechichian EG, Nasr MW. The Impact of Upper Face Botulinum Toxin Injections on Eyebrow Height and Forehead Lines: A Randomized Controlled Trial and an Algorithmic Approach to Forehead Injection. Plast Reconstr Surg. 2018 Nov;142(5):1212-1217. doi: 10.1097/PRS.0000000000004836.
PubMed 30102667
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Botulinum Toxin Injection in the Frontalis on Brow Height and Morphology: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03186001
- Acronym / sponsor ID
- USJ-06
- Conditions
- Browlift
- Keywords
- frontalis, frontal line, glabellar line, botulinum toxin, abobotulinum
- 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
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 14 Jun 2017 (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 botulinum toxin was first identified in the late 19th century(1). With its 40 different subtype this toxin is produced mainly by the gram positive anaerobic bacteria Clostridium Botulinum(2). This neurotoxin has great affinity to the neuro muscular junction preventing neurotransmitter release in the synaptic space of acetylcholine(3). The first clinical use was reported by Alan Scott in 1980(4). The most commonly used subtype is toxin A commercially found as BOTOX (onabotulinumtoxinA, Allergan, approved by FDA in 1989), Dysport (abobotulinumtoxinA, Medicis, approved by FDA in 2009) and Xeomin (incobotulinumtoxinA, Merz, approved by FDA in 2010). As for other commercial toxins botulinum neurotoxin serotype B product (MYOBLOC™). Neurotoxin Blast generally 12-15 weeks compared to 3-6 month for neurotoxin A. the FDA approved its use for strabismus in 1989(5), blepharospasm and hemifacial spasm in 1990(6,7), cervical dystonia in 2000(8), glabella in 2000, hyperhidrosis in 2004(9), chronic migrane and detrusor overactiviy in 2014. Other off-label uses have emerged like lanyngeal dysponia, chronic pain etc… (10). Multiple studies with a reduced number of patients have aimed to quantify the effect of botulinum toxin on brow higth. Some studies used injections only to the lateral part of the orbicularis,while others added a corrugator injection. We aimed in this study to compare a known techniques in brow lifting and associanting that with 2 frontalis injection techniques. The main objective is to evaluate the shape of the brow and the elevation in multiple brow landmarks before and after the injection and to see if the frontalis botulinum bloc causes brow ptosis
Detailed description
Botulinum toxin:
This toxin has been used clinically since 1989 with label (8) and off-label techniques(3).
This is a becoming a routine procedure for men and women with little side effects.
Brow lifting The ideal brow position is always an issue in plastic surgery(12). When face ages, the brow descends. Many approaches to a brow elevation are described in the literature. The first surgical approach is through a coronal incision(13), then came the temporal incision(14) and the direct approach(15), and finally the endoscopic approach(16). Non-surgical methods include radiofrequency(17), percutaneous sutures and botulinum toxin(11).
Standardized measure Anteroposterior pictures will be taken at rest pre and post injection. Using photoshop 7 brow landmarks will be measured to the midpupillary line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| v shape | Experimental | Drug: Abobotulinum toxin ATechnique 1Lateral orbicularis and corrugator injections: 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 1cm apart into the corrugator starting at the medial brow and extending laterally. Then 5 equally spaced injections, in a V pattern will be placed in the frontalis. The first injection between the medial brows, 2 injection 1cm below the hairline at the level of the lateral canthus and one injection equidistant to medial and lateral injection. |
| middle frontalis | Experimental | Drug: Abobotulinum toxin A: Lateral orbicularis and corrugator injections: 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 1cm apart into the corrugator starting at the medial brow and extending laterally. Then 5 equally spaced injections, in a straight pattern will be placed in the frontalis. One injection in the middle of the forehead, one on the same level of the lateral canthus and one between them. |
| high frontalis | Experimental | Drug: Abobotulinum toxin A: Lateral orbicularis and corrugator injections: 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 1cm apart into the corrugator starting at the medial brow and extending laterally.Then 5 equally spaced injections, in a straight pattern 1 cm below the hairline will be placed in the frontalis. One injection in the middle of the forehead, one on the same level of the lateral canthus and one between them. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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
- 30 Years to 60 Years
- Female
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 |
|---|---|---|
| Abobotulinum toxin AThe purpose of this study is to describe two safe and reproducible techniques upper face botulinum toxin injection. It will also describe the effect of both techniques on the eyebrow shape and height using quantitative, objective measurements and subjective scales | Drug | high frontalis, middle frontalis, v shape |
Primary outcome
Objective assessment
Time frame: 2 weeks
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, and medial limbus, mid pupil, lateral limbus, lateral canthus, and most lateral eyebrow.
5 secondary outcomes
1-Investigators Global Aesthetic Improvement Scale
Time frame: 2 weeks
2-Patient satisfaction
Time frame: 2 weeks
3-Brow Positioning Scale
Time frame: 2 weeks
4-Forehead Lines Scale:
Time frame: 2 weeks
5-Glabellar Lines Scale
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 30102667Jabbour SF, Awaida CJ, ElKhoury JS, Rayess YA, Makhoul RB, Kechichian EG, Nasr MW. The Impact of Upper Face Botulinum Toxin Injections on Eyebrow Height and Forehead Lines: A Randomized Controlled Trial and an Algorithmic Approach to Forehead Injection. Plast Reconstr Surg. 2018 Nov;142(5):1212-1217. doi: 10.1097/PRS.0000000000004836.
- Individual participant dataSharing planned: No
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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 Abobotulinum toxin A in people with Browlift, 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 3 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 14 Jun 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: 2 weeks). 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 NCT03186001, 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 14 Jun 2017.