Frontalis Botulinum Toxin

NCT ID: NCT03186001

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2017-08-01

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.

Conditions

Browlift

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

v shape

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.

Group Type: EXPERIMENTAL

Abobotulinum toxin A

Intervention Type: DRUG

The purpose of this study is to describe two safe and reproducible techniques upper face botulinum toxin injection. It will also describe the effect of both techniques on the eyebrow shape and height using quantitative, objective measurements and subjective scales

middle frontalis

: 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.

Group Type: EXPERIMENTAL

Abobotulinum toxin A

Intervention Type: DRUG

The purpose of this study is to describe two safe and reproducible techniques upper face botulinum toxin injection. It will also describe the effect of both techniques on the eyebrow shape and height using quantitative, objective measurements and subjective scales

high frontalis

: 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.

Group Type: EXPERIMENTAL

Abobotulinum toxin A

Intervention Type: DRUG

The purpose of this study is to describe two safe and reproducible techniques upper face botulinum toxin injection. It will also describe the effect of both techniques on the eyebrow shape and height using quantitative, objective measurements and subjective scales

Interventions

Abobotulinum toxin A

The purpose of this study is to describe two safe and reproducible techniques upper face botulinum toxin injection. It will also describe the effect of both techniques on the eyebrow shape and height using quantitative, objective measurements and subjective scales

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St Joseph University, Beirut, Lebanon

OTHER

Sponsor Role: lead

Responsible Party

samer jabbour

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Joseph University

Beirut, , Lebanon

Countries

Lebanon

Facility Contacts

joseph el khoury, M.D.

Role: primary

drjosephelkhoury@gmail.com

00961 70745258

References

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.

Reference Type: DERIVED

PMID: 30102667 (View on PubMed)

Other Identifiers

USJ-06

Identifier Type: -

Identifier Source: org_study_id