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Trial record 40 of 51 for:    Benign Essential Blepharospasm

Frontalis Botulinum Toxin

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ClinicalTrials.gov Identifier: NCT03186001
Recruitment Status : Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
samer jabbour, St Joseph University, Beirut, Lebanon

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

Condition or disease Intervention/treatment Phase
Browlift Drug: Abobotulinum toxin A Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: The Impact of Botulinum Toxin Injection in the Frontalis on Brow Height and Morphology: A Randomized Trial
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : August 1, 2017

Arm Intervention/treatment
Experimental: 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.
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

Experimental: 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.
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

Experimental: 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.
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




Primary Outcome Measures :
  1. Objective assessment [ Time Frame: 2 weeks ]
    Objective assessment will be done on anteroposterior views of pre-and-post injection photographs. The mid pupillary line will be drawn and the eyebrow vertical height will be measured from this line to the upper border of the brow at seven horizontal points: the most medial aspect of the eyebrow, medial canthus, and medial limbus, mid pupil, lateral limbus, lateral canthus, and most lateral eyebrow.


Secondary Outcome Measures :
  1. 1-Investigators Global Aesthetic Improvement Scale [ Time Frame: 2 weeks ]

    Improvement in Overall appearance of the upper face, as assessed by the 3 investigators (2 plastic surgeons and 1 dermatologist) using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on photographic assessment comparing post-treatment photos taken at day 15 post intervention to baseline photos (the lower eyelids and lower face will be cropped), to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows:

    1. Very Much Improved: optimal cosmetic results
    2. Much Improved: marked improvement in appearance from initial condition but not completely optimal
    3. Improved: obvious improvement in appearance from initial condition but additional treatments are advised
    4. No Change: the appearance is the same as the original condition
    5. Wose: the appearance is worse from the original condition

  2. 2-Patient satisfaction [ Time Frame: 2 weeks ]

    Patient satisfaction will be determined by a questionnaire completed at 15 days post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow:

    1. Very Satisfied
    2. Satisfied
    3. Dissatisfied
    4. Very Dissatisfied.

  3. 3-Brow Positioning Scale [ Time Frame: 2 weeks ]

    subjective evaluation using a photonumeric validated scale for eye brow positioning (evaluated by 2 plastic surgeons and 1 dermatologist) using pre and post injection photographs (taken at day 15 and 30) as follow: 0-Youthful, refreshed look and high-arch eyebrow

    1. Medium-arch eyebrow
    2. Slight arch of the eyebrow
    3. Flat arch of the eyebrow, visibility of folds, and tired appearance
    4. Flat eyebrow with barely any arch, marked visibility of folds, and very tired appearance

  4. 4-Forehead Lines Scale: [ Time Frame: 2 weeks ]

    subjective evaluation using a photonumeric validated scale for forehead lines at rest (evaluated by 2 plastic surgeons and 1 dermatologist) using pre and post injection photographs (taken at day 15 and 30) as follow: 0-None

    1. Minimal
    2. Moderate
    3. Deep
    4. Extreme

  5. 5-Glabellar Lines Scale [ Time Frame: 2 weeks ]

    subjective evaluation using a photonumeric validated scale for glabella lines at rest (evaluated by 2 plastic surgeons and 1 dermatologist) using pre and post injection photographs (taken at day 15) as follow: 0-No glabella lines

    1. Mild glabella lines
    2. Moderate glabella lines
    3. Severe glabella lines
    4. Very severe glabella lines



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186001


Locations
Lebanon
Saint Joseph University Recruiting
Beirut, Lebanon, 0000
Contact: joseph el khoury, M.D.    00961 70745258    drjosephelkhoury@gmail.com   
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon

Responsible Party: samer jabbour, M.D., St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT03186001     History of Changes
Other Study ID Numbers: USJ-06
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by samer jabbour, St Joseph University, Beirut, Lebanon:
frontalis
frontal line
glabellar line
botulinum toxin
abobotulinum

Additional relevant MeSH terms:
Botulinum Toxins
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents