Jowl Improvement With Injectable Fillers

Study Overview
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Brief Summary
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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 Juvederm Voluma. 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.

Detailed Description
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This study is proposed to evaluate the best protocol for achieving improvement in the sagging jawline. JUVÉDERM VOLUMA™ XC will be injected in each of 16 women with sagging of grades 1-3 using a published jawline evaluation scale. Patients will be randomized into 2 groups: Patient Group 1: 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) Patient Group 2: JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected 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) High-resolution photographs from multiple angles will be taken in identical lighting and position with the VISIA CR and with the Fotofinder at 4 weeks and 12 weeks. Additional real-time video telemedicine visits will take place at 6 months and 12 months. In addition, a 72-hour safety phone call will be completed with the subject after each injection session. All visit timing will be based on the last injection session. 2 blinded dermatologists will rate the patient's severity of jowling based on the Jawline Rating Scale (JRS) (1) at the 2- and 4-week visits. The patient will also rate their jowling based on the JRS as well as their satisfaction with the procedure.

Official Title
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Jowl Improvement With Injectable Fillers: Jawline Injections Alone vs Jawline and Cheek Injections

Conditions
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Jowls

Intervention / Treatment
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* Device: JUVÉDERM VOLUMA™ XC


Participation Criteria
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Eligibility Criteria
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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 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 was planning to undergo desensitization therapy during the term of the study. Patients who had porphyria, untreated epilepsy, or active autoimmune disease. Patients who had current cutaneous or mucosal inflammatory or infectious processes (e.g., acne, herpes, gum disease), abscess, an unhealed wound, or a cancerous or precancerous lesion, below the subnasal (study device injection may have been delayed for participants with a history of recurrent oral herpes lesions who take prophylactic doses of antiviral/herpes medication for at least 2 days before study treatment administration) Patients on a concurrent regimen of lidocaine or structurally-related local anesthetics (e.g., bupivacaine) or was on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism (e.g., cimetidine, beta-blockers) Patients on a regimen of anticoagulation therapy (e.g., warfarin, clopidogrel) or other prescription anticoagulation therapy. Patients on a regimen of medications (e.g., aspirin or ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or Gingko Biloba) within 10 days of undergoing study device injection (study device injection may have been delayed as necessary to accommodate this 10-day washout period) Patients who received any investigational product within 30 days prior to study enrollment or were planning to participate in another investigation during the course of this study. Patients who have begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasal area within 30 days before enrollment or was planning to begin using such products during the study (participants who had been on a regimen of such products for at least 30 days were eligible for the study if they intended to continue their regimen throughout the study).

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Both Jawline and Lateral (Zygomatic) Cheek Area Injections<br>JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected 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) | Device: JUVÉDERM VOLUMA™ XC<br>* Injectable gel<br>* Other names: non-animal hyaluronic acid;|
| Experimental: Jawline Injections<br>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) | Device: JUVÉDERM VOLUMA™ XC<br>* Injectable gel<br>* Other names: non-animal hyaluronic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at baseline | 2 blinded dermatologists will rate the patient's severity of jowling based on the Jawline Rating Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale (JRS). The scale is on a rating of 0 to 4. A lower number will mean a better outcome. | Baseline | 
| Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at 2 weeks | 2 blinded dermatologists will rate the patient's severity of jowling based on the Jawline Rating Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale (JRS). The scale is on a rating of 0 to 4. A lower number will mean a better outcome. | 2 weeks | 
| Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at 4 weeks | 2 blinded dermatologists will rate the patient's severity of jowling based on the Jawline Rating Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale (JRS). The scale is on a rating of 0 to 4. A lower number will mean a better outcome. | 4 weeks | 
| Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at 8 weeks | 2 blinded dermatologists will rate the patient's severity of jowling based on the Jawline Rating Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale (JRS). The scale is on a rating of 0 to 4. A lower number will mean a better outcome. | 8 weeks | 
| Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at 12 or 16 weeks | 2 blinded dermatologists will rate the patient's severity of jowling based on the Jawline Rating Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale (JRS). The scale is on a rating of 0 to 4. A lower number will mean a better outcome. | 3 months from last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of abnormal eye exam (Confrontational Visual Fields Exam) findings (Safety) | -Ophthalmologic exams that include Confrontational Visual Fields Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. | up to 18 months | 
| Incidence of abnormal eye exam (Snellen Eye Exam) findings (Safety) | -Ophthalmologic exams that include Snellen Eye Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. | up to 18 months | 
| Incidence of abnormal eye exam (Ocular Motility Exam) findings (Safety) | -Ophthalmologic exams that include Ocular Motility Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. | up to 18 months | 
| Incidence of abnormal cranial nerves II, III, IV and VII assessments findings (Safety) | To further assess vision and oculomotor function, cranial nerves II, III, IV, and VII will be assessed (left and right sides separately). To assess lower face function, cranial nerves V, VII, IX, X, and XII will be assessed. These exams will be performed prior to any treatment, 30 minutes after treatment, and at all follow up visits. | up to 18 months | 
| Adverse events | Adverse events will be recorded until 12 months after last treatment. | up to 12 months after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jowls, Lower Face Laxity, Filler, JUVÉDERM VOLUMA™ XC., Melolabial Folds, Wrinkles