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

Brow Lifting Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02942303
• Other study ID #: USJ-03
• Status: Recruiting
• Phase: Phase 4
• First received: October 20, 2016
• Last updated: May 11, 2017
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brow Lifting

Intervention

Drug:
• Dysport

Procedure:
• lateral orbicularis injection

• Lateral orbicularis + corrugator injection

Locations

Country	Name	City	State
Lebanon	Hotel Dieu De France	Beirut	Aschrafieh

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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