N/A
N=16
Jowl Improvement With Injectable Fillers
Jowls
Bottom Line
View on ClinicalTrials.gov: NCT04389866 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. — 2.214; 2.071; 1.857; 1.857 score on a scale — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- JUVÉDERM VOLUMA™ XC (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Advanced Dermatology
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. |
2.214; 2.071; 1.857; 1.857; .357; .214 | 0.018 sig |
| SECONDARY Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. |
2.357; 2.357; 1.357; 1.643; 1.0; .714 | 0.00000031 sig |
| SECONDARY Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. |
2.286; 2.429; 1.714; 1.714; .571; .714 | 0.014 sig |
| SECONDARY Number of Participants With Abnormal Confrontational Visual Fields Exam Findings |
0; 0 | — |
| SECONDARY Number of Participants With Abnormal Eye Exam Findings |
0; 0 | — |
| SECONDARY Number of Participants With Abnormal Ocular Motility Exam Findings |
0; 0 | — |
| SECONDARY Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments Findings |
1; 0 | — |
| SECONDARY Number of Participants With Adverse Events |
2; 6; 6; 3; 4; 5 | — |
| SECONDARY Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. |
1.857; 1.857 | — |
| SECONDARY Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. |
1.357; 1.643 | — |
| SECONDARY Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. |
1.714; 1.714 | — |
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.
Eligibility Criteria
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
- 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.
- Patients who experienced trauma to the chin and jaw area within 6 months before enrollment or had residual deficiencies, deformities, or scarring.
- Patients with a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein, or
Data sourced from ClinicalTrials.gov (NCT04389866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.