The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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Brow Lifting

Intervention / Treatment
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* Drug: Dysport
* Procedure: lateral orbicularis injection
* Procedure: Lateral orbicularis + corrugator injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Technique 1: Lateral orbicularis injections<br>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. | Drug: Dysport<br> <br> * Other names: abobotulinumtoxineA;Procedure: lateral orbicularis injection<br> <br> |
| Active Comparator: 2. Technique 2: Lateral orbicularis and Corrugator injections<br>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 | Drug: Dysport<br> <br> * Other names: abobotulinumtoxineA;Procedure: Lateral orbicularis + corrugator injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 days post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxin, Rejuvenation, Brow lift, Eyebrow.