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Frontalis Botulinum Toxin

NCT03186001 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-14

No results posted yet for this study

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

Conditions

  • Browlift

Interventions

DRUG

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

Sponsors & Collaborators

  • St Joseph University, Beirut, Lebanon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2017-08-01
Completion
2017-08-01

Countries

  • Lebanon

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186001 on ClinicalTrials.gov