Frontalis Botulinum Toxin

St Joseph University, Beirut, Lebanon

Status and phase: Unknown; Phase 4

Conditions: Browlift

Treatments: Drug: Abobotulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT03186001

USJ-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

v shape

Experimental group

Description:

Technique 1Lateral 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 1cm apart into the corrugator starting at the medial brow and extending laterally. Then 5 equally spaced injections, in a V pattern will be placed in the frontalis. The first injection between the medial brows, 2 injection 1cm below the hairline at the level of the lateral canthus and one injection equidistant to medial and lateral injection.

Treatment:

Drug: Abobotulinum toxin A

middle frontalis

Experimental group

Description:

: 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 1cm apart into the corrugator starting at the medial brow and extending laterally. Then 5 equally spaced injections, in a straight pattern will be placed in the frontalis. One injection in the middle of the forehead, one on the same level of the lateral canthus and one between them.

Treatment:

Drug: Abobotulinum toxin A

high frontalis

Experimental group

Description:

: 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 1cm apart into the corrugator starting at the medial brow and extending laterally.Then 5 equally spaced injections, in a straight pattern 1 cm below the hairline will be placed in the frontalis. One injection in the middle of the forehead, one on the same level of the lateral canthus and one between them.

Treatment:

Drug: Abobotulinum toxin A