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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03186001 |
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Date of registration:
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12/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Frontalis Botulinum Toxin
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Scientific title:
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The Impact of Botulinum Toxin Injection in the Frontalis on Brow Height and Morphology: A Randomized Trial |
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Date of first enrolment:
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July 1, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03186001 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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joseph el khoury, M.D. |
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Address:
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Telephone:
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00961 70745258 |
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Email:
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drjosephelkhoury@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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
2. 30 Years to 60 Years
3. Female
Exclusion Criteria:
1. Patients with previous periorbital/forehead surgery
2. Patients who plucked the upper eyebrow margin
3. Patients with eyebrow tatoos
4. Patients with upper face botulinum toxin injection in the past 12 months
5. Patients with resorbable upper face fillers injection in the past 12 months
6. Patients with previous permanent upper face fillers injection
7. Pregnant patients
8. Lactating patients
9. Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert
syndrome)
10. Patients using medication that could potentiate the effect of botulinum (ex:
aminoglycoside antibiotics)
11. Patients with sensitivity to botulinum toxin or human albumin
Age minimum:
30 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Browlift
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Intervention(s)
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Drug: Abobotulinum toxin A
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Primary Outcome(s)
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Objective assessment
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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3-Brow Positioning Scale
[Time Frame: 2 weeks]
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5-Glabellar Lines Scale
[Time Frame: 2 weeks]
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1-Investigators Global Aesthetic Improvement Scale
[Time Frame: 2 weeks]
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4-Forehead Lines Scale:
[Time Frame: 2 weeks]
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2-Patient satisfaction
[Time Frame: 2 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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