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

Phase 4
Conditions
Brow Lifting
Interventions
Drug: Dysport
Procedure: lateral orbicularis injection
Procedure: Lateral orbicularis + corrugator injection
Registration Number
NCT02942303
Lead Sponsor
St Joseph University, Beirut, Lebanon
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
30
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Technique 1: Lateral orbicularis injectionslateral 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 injectionsLateral 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
Technique 1: Lateral orbicularis injectionsDysport5 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 injectionsDysport5 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
Primary Outcome Measures
NameTimeMethod
Objective assessment15 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.

Secondary Outcome Measures
NameTimeMethod
Patient satisfaction15 days post treatment

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:

1. Very Satisfied

2. Satisfied

3. Dissatisfied

4. Very Dissatisfied.

Trial Locations

Locations (1)

Hotel Dieu De France

🇱🇧

Beirut, Aschrafieh, Lebanon

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