- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02864511
Botulinum Toxin for Neck Rejuvenation
Nefertiti Lift for Neck Rejuvenation: Assessing Efficiency and Re-defining Patient Selection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Aschrafieh
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Beirut, Aschrafieh, Lebanon, 00961
- Hotel Dieu de France
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
15-25 days post treatment
|
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 |
15-25 days post treatment
|
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 |
15-25 days post treatment
|
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 |
15-25 days post treatment
|
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 |
15-25 days post treatment
|
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 |
15-25 days post treatment
|
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 |
15-25 days post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigators Global Aesthetic Improvement Scale
Time Frame: 15-25 days post treatment
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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:
|
15-25 days post treatment
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Subject Global Aesthetic Improvement Scale
Time Frame: 15-25 days post treatment
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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:
|
15-25 days post treatment
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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:
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15-25 days post treatment
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Patient willingness to repeat the procedure
Time Frame: 15-25 days post treatment
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Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response
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15-25 days post treatment
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Patient willingness to recommend the procedure
Time Frame: 15-25 days post treatment
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Patient willingness to recommend the procedure to a friend will be assessed by a simple question with a Yes or No response
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15-25 days post treatment
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Assessment of Pain during treatment
Time Frame: At the day of the procedure
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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
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At the day of the procedure
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Collaborators and Investigators
Publications and helpful links
General Publications
- Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x.
- Sattler G, Carruthers A, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, Mohrmann C, Narins RS, Pooth R, Rzany B, Buchner L, Benter U, Breitscheidel L, de Maio M. Validated assessment scale for neck volume. Dermatol Surg. 2012 Feb;38(2 Spec No.):343-50. doi: 10.1111/j.1524-4725.2011.02253.x.
- Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated grading scale for marionette lines. Dermatol Surg. 2008 Nov;34 Suppl 2:S167-72. doi: 10.1111/j.1524-4725.2008.34366.x.
- Geister TL, Blessmann-Gurk B, Rzany B, Harrington L, Gortelmeyer R, Pooth R. Validated assessment scale for platysmal bands. Dermatol Surg. 2013 Aug;39(8):1217-25. doi: 10.1111/dsu.12240. Epub 2013 May 7.
- Gupta S, Biskup N, Mattison G, Leis A. Development and Validation of a Clinical Assessment Tool for Platysmal Banding in Cervicomental Aesthetics of the Female Neck. Aesthet Surg J. 2015 Aug;35(6):NP141-6. doi: 10.1093/asj/sju160.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USJ-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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