- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942303
The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial
May 11, 2017 updated by: samer jabbour, St Joseph University, Beirut, Lebanon
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aschrafieh
-
Beirut, Aschrafieh, Lebanon, 00961
- Recruiting
- Hotel Dieu de France
-
Contact:
- samer jabbour, M.D.
- Phone Number: 009613416234
- Email: samermed@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Technique 1: Lateral orbicularis 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.
|
Other Names:
|
Active Comparator: 2. Technique 2: 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 into the corrugator at the medial brow
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 days post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 15 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:
|
15 days post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
May 1, 2017
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
October 20, 2016
First Submitted That Met QC Criteria
October 21, 2016
First Posted (Estimate)
October 24, 2016
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USJ-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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