Jowl Improvement With Injectable Fillers

NCT04389866 | Completed Results FDA Device

• 1 other identifier: 10001 Jowl Voluma
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective clinical study to demonstrate a reduction in jowling and laxity of the jawline that can be achieved following facial volume enhancement using JUVÉDERM VOLUMA™ XC (0.3% w/w lidocaine). The secondary measure will be if this can be achieved with Jawline injection only, or if a superior result can be obtained with both cheek and jowl injection.

Conditions

Jowls

Keywords

Jowls; Lower Face Laxity; Filler; JUVÉDERM VOLUMA™ XC.; Melolabial Folds; Wrinkles

Outcome Measures

Primary Outcomes (1)

• Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.

  The primary outcome is a reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether initial or touch-up) based on one blinded dermatologist rating. (A lower number will mean a better outcome) All subject data in respective groups were averaged into a single value at each time point. To clarify the Time Point "4 Weeks from last injection" it means 8 to 12 weeks after baseline as subjects were eligible for treatment 4 weeks after baseline and possible retreatment 8 weeks after baseline. The study wanted to capture results 4 weeks after last injection.

  Baseline to 4 weeks after last injection.

Secondary Outcomes (10)

• Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.

  Baseline to 4 weeks after last injection.

• Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.

  Baseline to 4 weeks after last injection.

• Number of Participants With Abnormal Confrontational Visual Fields Exam Findings

  From initial treatment visit until12 weeks post last injection

• Number of Participants With Abnormal Eye Exam Findings

  From initial treatment visit until12 weeks post last injection

• Number of Participants With Abnormal Ocular Motility Exam Findings

  From initial treatment visit until 12 weeks post final injection

Study Arms (2)

Both Jawline and Lateral (Zygomatic) Cheek Area Injections

EXPERIMENTAL

JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5)

Device: JUVÉDERM VOLUMA™ XC

Jawline Injections

EXPERIMENTAL

JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2)

Device: JUVÉDERM VOLUMA™ XC

Interventions

JUVÉDERM VOLUMA™ XC DEVICE

Injectable gel

Also known as: non-animal hyaluronic acid

Both Jawline and Lateral (Zygomatic) Cheek Area Injections; Jawline Injections

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Jowling grade 2-3 by the Lower Face Jawline at Rest Scale (1), by both MD evaluator and patient.
• Female patients must not be pregnant or trying to get pregnant and must have negative pregnancy tests before treatment.
• Non-pregnant females ages 35-75 in good general health.
• A study participant must be able to give proper informed consent in writing and be willing to follow the treatment schedule and undertake to carry out all necessary precautions and instructions.
• Able to participate in telemedicine video visits.
• Able to understand the requirements of the study and willing and able to follow all study procedures and attend all study visits, and successfully complete the study.
• Willing to refrain from any other cosmetic procedures on the face including surgery, thread lifting, botulinum toxin in the masseters, jawline, neck, lips or chin, chemical peels, lasers or energy-based devices meant to improve volume or laxity of the face, and additional injectable fillers from the first visit through 12 months after last injection session.

You may not qualify if:

• Pregnancy or nursing
• Hyaluronic acid filler injections in the past 6 months in the lower face or unwilling to refrain from such injections other than in the study for the duration of the study.
• Radiesse or Sculptra in the past 24 months in the lower face
• Permanent fillers or injectable fat at any time in the past.
• Facial surgery, tissue tightening, or laser treatments within the past 24 months in the lower face, or unwilling to refrain from having these treatments for the duration of the study.
• History of keloid or scar formation
• Unwillingness to refrain from excessive sun exposure or tanning beds during the healing process
• Taking any medications or supplements that will increase the potential for bruising, or discontinuation of same for 10 days prior to the procedure if medically allowed. These include but are not limited to aspirin of any dosage, any prescription blood thinner, vitamin E, and fish oil.
• Any of the following significant medical problems: diabetes, obesity, autoimmune disease, cancer, inflammation at the site of injection, current infection any place on the body, dental work in the prior 2 weeks or scheduled for the post-treatment 2-week period, dementia, facial nerve abnormalities, history of blood clots, Bell's Palsy or any neurological condition affecting the facial muscles or nerves.
• Prior tattoos, piercings, facial hair, or scars below and including the subnasal area that could interfere with visual assessment of the chin, jowls, jawline, and could promote bias in the evaluation of improvement or safety.
• Known allergy or sensitivity to any components of the injection material, lidocaine, or hyaluronidase.
• Current enrollment in any other investigational drug or device trial.
• Any condition that the investigator believes might interfere with study results or put the subject at significant risk with participation.
• Patients planning to undergo any dental procedure (other than prophylaxis and dental) fillings) during the study will be excluded in order to reduce risks related to seeding infection during injections.
• Patients who have undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck, or botulinum toxin treatment below the subnasal region (including injections to the masseter muscles) within 6 months before enrollment or was planning to undergo any of these procedures during the study.

Sponsors & Collaborators

• Advanced Dermatology: lead
• Allergan: collaborator

Study Sites (1)

Advanced Dermatology

Lincolnshire, Illinois, 60069, United States

Location

Limitations and Caveats

The limitations and caveats are the following: Small sample size, limited to females only, interrupted by COVID with some discontinuous visits, 2 patients were evaluated as mild at baseline by the blinded physician and they should have been excluded.

Results Point of Contact

• Title: Dr. Amy Forman Taub
• Organization: Advanced Dermatology

drtaub@advdermatology.com

8474596400

Study Officials

• Amy Taub, MD

  Advanced Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 15, 2020
• Study Start: September 25, 2020
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2024-01

Locations

US (1)