Clinical trial NCT02864511: Botulinum Toxin for Neck Rejuvenation
Official title: Nefertiti Lift for Neck Rejuvenation: Assessing Efficiency and Re-defining Patient Selection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Botulinum Toxin, Rejuvenation, Neck, Therapy
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Neck volume using a validated scale from the Summit Scale II (1)
timeFrame: 15-25 days post treatment
measure: Jowls at rest using a validated scale from the Summit Scale II (2)
timeFrame: 15-25 days post treatment
measure: Marionette lines at rest using a validated scale from the Summit Scale II (3)
timeFrame: 15-25 days post treatment
measure: Oral commissures at rest using a validated scale from the Summit Scale II (2)
timeFrame: 15-25 days post treatment
measure: Platysmal bands at maximal contraction using a validated scale (4)
timeFrame: 15-25 days post treatment
measure: Platysmal bands at rest using a validated scale (5)
timeFrame: 15-25 days post treatment
measure: Mandibular definition change with maximal contraction will be assessed by a 2-point scale
timeFrame: 15-25 days post treatment
Secondary outcomes:
measure: Investigators Global Aesthetic Improvement Scale
timeFrame: 15-25 days post treatment
measure: Subject Global Aesthetic Improvement Scale
timeFrame: 15-25 days post treatment
measure: Patient satisfaction
timeFrame: 15-25 days post treatment
measure: Patient willingness to repeat the procedure
timeFrame: 15-25 days post treatment
measure: Patient willingness to recommend the procedure
timeFrame: 15-25 days post treatment
measure: Assessment of Pain during treatment
timeFrame: At the day of the procedure
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu De France
state: Aschrafieh
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.