Jowl Improvement With Injectable Fillers (NCT04389866) | Clinical Trial Compass
CompletedNot Applicable
Jowl Improvement With Injectable Fillers
United States16 participantsStarted 2020-09-25
Plain-language 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.
Who can participate
Age range35 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.
Timeframe: Baseline to 4 weeks after last injection.
. 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.