Botulinum Toxin for Neck Rejuvenation

NCT ID: NCT02864511

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Botulinum Toxin, Rejuvenation, Neck, Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Group Type EXPERIMENTAL

Nefertiti lift

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nefertiti lift

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

neck rejuvenation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St Joseph University, Beirut, Lebanon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

samer jabbour

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hotel Dieu De France

Beirut, Aschrafieh, Lebanon

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Lebanon

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22316190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22316189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19021675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23650974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26229133 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

USJ-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.