Clinical trial NCT03186001: Frontalis Botulinum Toxin
Official title: The Impact of Botulinum Toxin Injection in the Frontalis on Brow Height and Morphology: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Browlift
Keywords: frontalis
frontal line
glabellar line
botulinum toxin
abobotulinum
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The botulinum toxin was first identified in the late 19th century(1). With its 40 different subtype this toxin is produced mainly by the gram positive anaerobic bacteria Clostridium Botulinum(2). This neurotoxin has great affinity to the neuro muscular junction preventing neurotransmitter release in the synaptic space of acetylcholine(3). The first clinical use was reported by Alan Scott in 1980(4). The most commonly used subtype is toxin A commercially found as BOTOX (onabotulinumtoxinA, Allergan, approved by FDA in 1989), Dysport (abobotulinumtoxinA, Medicis, approved by FDA in 2009) and Xeomin (incobotulinumtoxinA, Merz, approved by FDA in 2010). As for other commercial toxins botulinum neurotoxin serotype B product (MYOBLOC™). Neurotoxin Blast generally 12-15 weeks compared to 3-6 month for neurotoxin A. the FDA approved its use for strabismus in 1989(5), blepharospasm and hemifacial spasm in 1990(6,7), cervical dystonia in 2000(8), glabella in 2000, hyperhidrosis in 2004(9), chronic migrane and detrusor overactiviy in 2014. Other off-label uses have emerged like lanyngeal dysponia, chronic pain etc... (10). Multiple studies with a reduced number of patients have aimed to quantify the effect of botulinum toxin on brow higth. Some studies used injections only to the lateral part of the orbicularis,while others added a corrugator injection. We aimed in this study to compare a known techniques in brow lifting and associanting that with 2 frontalis injection techniques. The main objective is to evaluate the shape of the brow and the elevation in multiple brow landmarks before and after the injection and to see if the frontalis botulinum bloc causes brow ptosis

Detailed description: Botulinum toxin:

This toxin has been used clinically since 1989 with label (8) and off-label techniques(3).

This is a becoming a routine procedure for men and women with little side effects.

Brow lifting The ideal brow position is always an issue in plastic surgery(12). When face ages, the brow descends. Many approaches to a brow elevation are described in the literature. The first surgical approach is through a coronal incision(13), then came the temporal incision(14) and the direct approach(15), and finally the endoscopic approach(16). Non-surgical methods include radiofrequency(17), percutaneous sutures and botulinum toxin(11).

Standardized measure Anteroposterior pictures will be taken at rest pre and post injection. Using photoshop 7 brow landmarks will be measured to the midpupillary line.

Eligibility criteria: 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

Primary outcomes:
measure: Objective assessment
timeFrame: 2 weeks
Secondary outcomes:
measure: 1-Investigators Global Aesthetic Improvement Scale
timeFrame: 2 weeks
measure: 2-Patient satisfaction
timeFrame: 2 weeks
measure: 3-Brow Positioning Scale
timeFrame: 2 weeks
measure: 4-Forehead Lines Scale:
timeFrame: 2 weeks
measure: 5-Glabellar Lines Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph University
Study officials:
References:
citation: Jabbour SF, Awaida CJ, ElKhoury JS, Rayess YA, Makhoul RB, Kechichian EG, Nasr MW. The Impact of Upper Face Botulinum Toxin Injections on Eyebrow Height and Forehead Lines: A Randomized Controlled Trial and an Algorithmic Approach to Forehead Injection. Plast Reconstr Surg. 2018 Nov;142(5):1212-1217. doi: 10.1097/PRS.0000000000004836.