Botulinum Toxin for Neck Rejuvenation

NCT02864511 | Completed

• 1 other identifier: USJ-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Botulinum Toxin, Rejuvenation, Neck, Therapy

Outcome Measures

Primary Outcomes (7)

• 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

  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

  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

  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

  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

  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

  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

  15-25 days post treatment

Secondary Outcomes (6)

• Investigators Global Aesthetic Improvement Scale

  15-25 days post treatment

• Subject Global Aesthetic Improvement Scale

  15-25 days post treatment

• Patient satisfaction

  15-25 days post treatment

• Patient willingness to repeat the procedure

  15-25 days post treatment

• Patient willingness to recommend the procedure

  15-25 days post treatment

Study Arms (1)

Intervention group

EXPERIMENTAL

Procedure: Nefertiti lift

Interventions

Nefertiti lift PROCEDURE

Also known as: neck rejuvenation

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Hotel Dieu De France

Beirut, Aschrafieh, 00961, Lebanon

Location

Related Publications (5)

• 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.

  PMID: 22316190 BACKGROUND

• 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.

  PMID: 22316189 BACKGROUND

• 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.

  PMID: 19021675 BACKGROUND

• 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.

  PMID: 23650974 BACKGROUND

• 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.

  PMID: 26229133 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

LE (1)