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Completed

NCT Number: NCT02864511

Botulinum Toxin for Neck Rejuvenation

The purpose of this study is to describe a safe and consistent technique for neck rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the intervention and determine the patients that would benefit most.

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Key information

Conditions

Botulinum Toxin, Rejuvenation, Neck, Therapy

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

About this study

The abobotulinumtoxinA will be used for the Nefertiti lift The abobotulinumtoxinA will be prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction)

Injection points:

  • A series of 4 injection points 1-2 cm apart on a horizontal line under the mandible posterior to the hypothetical line were the nasolabial fold meets the mandible
  • If present, injection of each platysmal band every 2 cm with 2 to 4 injection points per band (Injection of platysmal band will be done by holding the band between 2 fingers and injecting intramuscularly) For all injection points 5 units per point of abobotulinumtoxinA will be used

A maximum of 125 units of abobotulinumtoxinA will be allowed for the global neck treatment

Follow up will be done at 15 days for retouching or for post op pictures if no retouching is needed. if retouching is needed post injection pictures will be taken 10 days post retouching

Retouching: each residual platysmal band will be reinjected every 2 cm with 2 to 4 injection points per band (Injection of platysmal band will be done by holding the band between 2 fingers and injecting intramuscularly) (5 units per point of abobotulinumtoxinA will be used)

A total of 30 patients will be recruited

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patients presenting to our clinic for neck rejuvenation who:

  • Were deemed nonsurgical candidates for neck rejuvenation
  • Were not willing to undergo invasive surgical procedures
  • Had a medical contraindication to surgery

Exclusion criteria

  • Patients with lower face botulinum toxin injection in the past 12 months
  • Patients with resorbable lower face fillers injection in the past 12 months
  • Patients with previous permanent lower face fillers injection
  • Pregnant patients
  • Lactating patients
  • Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
  • Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
  • Patients with sensitivity to botulinum toxin or human albumin

Treatment and study plan

Nefertiti lift

Procedure

Other names: neck rejuvenation

Primary outcomes

  1. Neck volume using a validated scale from the Summit Scale II (1)

    Time frame: 15-25 days post treatment

    The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos

    No Sagging

    Mild Sagging

    Moderate Sagging

    Severe Sagging

    Very Severe Sagging

  2. Jowls at rest using a validated scale from the Summit Scale II (2)

    Time frame: 15-25 days post treatment

    The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos

    No Sagging

    Mild Sagging

    Moderate Sagging

    Severe Sagging

    Very Severe Sagging

  3. Marionette lines at rest using a validated scale from the Summit Scale II (3)

    Time frame: 15-25 days post treatment

    The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos

    No visible folds: continuous skin lines

    Shallow but visible folds with slight indentation

    Moderately deep folds, clear feature at normal appearance, but not when stretched

    Very long and deep folds, prominent facial feature

    Extremely long and deep folds; detrimental facial appearance

  4. Oral commissures at rest using a validated scale from the Summit Scale II (2)

    Time frame: 15-25 days post treatment

    The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos

    No Downturn

    Mild Downturn

    Moderate Downturn

    Severe Downturn

    Very Severe Downturn

  5. Platysmal bands at maximal contraction using a validated scale (4)

    Time frame: 15-25 days post treatment

    The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos

    No relevant prominence of platysmal bands

    Mild prominence of platysmal bands

    Moderate prominence of platysmal bands

    Severe prominence of platysmal bands

    Very severe prominence of platysmal bands

  6. Platysmal bands at rest using a validated scale (5)

    Time frame: 15-25 days post treatment

    The assessment will be done by 2 plastic surgeons and 1 dermatologist. Pre and post injection scores will be calculated by the independent evaluators based on the photographic scale . The 3 evaluators will be blinded to the pre or post injection status of the photos

    No platsymal bands visible at rest

    Mild platysmal bands evident at rest. Bands do not appear along the full length of the neck.

    Mild platysmal bands evident along the full length of the neck at rest, less than 5 mm of elevation from the surrounding tissue.

    Moderate platsymal bandsvisible at rest along the full length of the neck, elevation at least 5 mm from the surrounding tissue.

    Severe platsymal bands along the full length of the neck at rest, elevation at least 5 mm from the surrounding tissue, with additional soft tissue ptotic banding present laterally

  7. Mandibular definition change with maximal contraction will be assessed by a 2-point scale

    Time frame: 15-25 days post treatment

    The assessment of the pre-injection photos will be done by 2 plastic surgeons and 1 dermatologist

    Mandibular contour does not worsen with platysmal contraction

    Mandibular contour worsen with platysmal contraction

Secondary outcomes

  1. Investigators Global Aesthetic Improvement Scale

    Time frame: 15-25 days post treatment

    Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the investigators using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows:

    • Very Much Improved: optimal cosmetic results
    • Much Improved: marked improvement in appearance from initial condition but not completely optimal
    • Improved: obvious improvement in appearance from initial condition but additional treatments are advised
    • No Change: the appearance is the same as the original condition
    • Worse: the appearance is worse from the original condition

  2. Subject Global Aesthetic Improvement Scale

    Time frame: 15-25 days post treatment

    Improvement in Overall appearance (global neck, jowls, skin laxity, platysmal bands, mandibular contour), as assessed by the subject using the Global Aesthetic Improvement Scale (GAIS). GAIS will be completed based on a live assessment of the subject with a mirror in hand for real time assessment and and a photographic assessment comparing post-treatment photos taken at day 15-25 post intervention to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) as follows:

    • Very Much Improved: optimal cosmetic results
    • Much Improved: marked improvement in appearance from initial condition but not completely optimal
    • Improved: obvious improvement in appearance from initial condition but additional treatments are advised
    • No Change: the appearance is the same as the original condition
    • Worse: the appearance is worse from the original condition

  3. Patient satisfaction

    Time frame: 15-25 days post treatment

    Patient satisfaction will be determined by a questionnaire completed at 15-25 days post-treatment. Subjects will indicate how satisfied they are on a 4-point scale (1-4) as follow:

    • Very Satisfied
    • Satisfied
    • Dissatisfied
    • Very Dissatisfied.

  4. Patient willingness to repeat the procedure

    Time frame: 15-25 days post treatment

    Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response

  5. Patient willingness to recommend the procedure

    Time frame: 15-25 days post treatment

    Patient willingness to recommend the procedure to a friend will be assessed by a simple question with a Yes or No response

  6. Assessment of Pain during treatment

    Time frame: At the day of the procedure

    Subjects' pain during the treatment will be recorded using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

Nefertiti Lift for Neck Rejuvenation: Assessing Efficiency and Re-defining Patient Selection

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 12, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.