Botulinum Toxin, Rejuvenation, Neck, TherapyNCT02864511

Botulinum Toxin for Neck Rejuvenation

A study testing Nefertiti lift in people with Botulinum Toxin, Rejuvenation, Neck, Therapy, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for: Botulinum Toxin, Rejuvenation, Neck, Therapy
What is being tested?: Nefertiti lift
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteLebanon
Study dates: Aug 2016to Oct 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

Hotel Dieu De France
Beirut, Aschrafieh, 00961

Other trials in Lebanon

About this study

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

Read the 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

Conditions: Botulinum Toxin, Rejuvenation, Neck, Therapy
Being tested: Nefertiti lift

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nefertiti liftProcedure or surgery
Also called neck rejuvenation

Study groups in NCT02864511
Study group	Role	What they receive
Intervention group	Experimental	Not described Receives: Procedure: Nefertiti lift

What is being measured

The primary outcome is the main question the study is designed to answer.

Neck volume using a validated scale from the Summit Scale II (1)
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
Measured: 15-25 days post treatment
Jowls at rest using a validated scale from the Summit Scale II (2)
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
Measured: 15-25 days post treatment
Marionette lines at rest using a validated scale from the Summit Scale II (3)
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
Measured: 15-25 days post treatment
Oral commissures at rest using a validated scale from the Summit Scale II (2)
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
Measured: 15-25 days post treatment
Platysmal bands at maximal contraction using a validated scale (4)
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
Measured: 15-25 days post treatment
Platysmal bands at rest using a validated scale (5)
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
Measured: 15-25 days post treatment
Mandibular definition change with maximal contraction will be assessed by a 2-point scale
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
Measured: 15-25 days post treatment

Secondary outcomes (6)

Investigators Global Aesthetic Improvement Scale
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:
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. Worse: the appearance is worse from the original condition
Measured: 15-25 days post treatment
Subject Global Aesthetic Improvement Scale
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:
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. Worse: the appearance is worse from the original condition
Measured: 15-25 days post treatment
Patient satisfaction
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:
1. Very Satisfied
2. Satisfied
3. Dissatisfied
4. Very Dissatisfied.
Measured: 15-25 days post treatment
Patient willingness to repeat the procedure
Patient willingness to repeat the procedure will be assessed by a simple question with a Yes or No response
Measured: 15-25 days post treatment
Patient willingness to recommend the procedure
Patient willingness to recommend the procedure to a friend will be assessed by a simple question with a Yes or No response
Measured: 15-25 days post treatment
Assessment of Pain during treatment
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
Measured: At the day of the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Oct 2016

First posted12 Aug 2016 (estimated)
Study startAug 2016
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Botulinum Toxin, Rejuvenation, Neck, TherapyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02864511
Sponsor's protocol ID: USJ-01
Status last verified: Oct 2016
First submitted: 9 Aug 2016
Last updated: 11 Oct 2016
Results posted: No

Publications

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.
PubMed 22316190
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.
PubMed 22316189
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.
PubMed 19021675
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.
PubMed 23650974
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.
PubMed 26229133

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nefertiti Lift for Neck Rejuvenation: Assessing Efficiency and Re-defining Patient Selection
ClinicalTrials.gov ID: NCT02864511
Acronym / sponsor ID: USJ-01
Conditions: Botulinum Toxin, Rejuvenation, Neck, Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: St Joseph University, Beirut, LebanonUniversity, hospital or other
Study start: Aug 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 12 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

A total of 30 patients will be recruited

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention group	Experimental	Procedure: Nefertiti lift

Who may qualify

Ages: 18 to 90 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nefertiti liftAlso: neck rejuvenation	Procedure or surgery	Intervention group

Primary outcome

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
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
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
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
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
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
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

6 secondary outcomes

Investigators Global Aesthetic Improvement Scale
Time frame: 15-25 days post treatment
Subject Global Aesthetic Improvement Scale
Time frame: 15-25 days post treatment
Patient satisfaction
Time frame: 15-25 days post treatment
Patient willingness to repeat the procedure
Time frame: 15-25 days post treatment
Patient willingness to recommend the procedure
Time frame: 15-25 days post treatment
Assessment of Pain during treatment
Time frame: At the day of the procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
Background: PubMed 22316190Sattler 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.
Background: PubMed 22316189Narins 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.
Background: PubMed 19021675Carruthers 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.
Background: PubMed 23650974Geister 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.
Background: PubMed 26229133Gupta 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nefertiti lift in people with Botulinum Toxin, Rejuvenation, Neck, Therapy, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck volume using a validated scale from the Summit Scale II (1) (time frame: 15-25 days post treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864511, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.