JUVÉDERM VOLUX® for Chin Retrusion in China

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.

Official Title
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A Randomized, Multicenter, No-Treatment Control Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLUX® Injectable Gel for the Enhancement of the Chin to Correct Moderate to Severe Retrusion in Chinese Adults

Conditions
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Chin Retrusion

Intervention / Treatment
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* Device: JUVÉDERM VOLUX®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be at least 18 years of age at the time of signing the ICF Male and female Participants of Chinese descent Participants seeking improvement of chin retrusion Chin retrusion (G-Sn-Pog angle of < 172.5°) based on calculations of facial angle derived from digital images obtained using Canfield imaging equipment and software Has moderate to severe chin retrusion on the CACRS as determined by EI 2D image evaluation Has a reasonable goal for aesthetic improvement in chin retrusion and is able to achieve a 1-point improvement in CACRS score with study intervention in the judgment of TI Capable of giving signed informed consent as described in Appendix 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Written informed consent from the participant has been obtained prior to any study-related procedures Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable Exclusion Criteria: History of tendency to develop hypertrophic scarring History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or streptococcal protein Active autoimmune disease Current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion in the chin area (participants with a history of recurrent oral herpes are eligible if prophylactic antiviral/herpes medication is administered for 2 days before study intervention) Impaired cardiac conduction, impaired hepatic function, or impaired renal function according to the judgment of the TI based on medical history, laboratory testing results, and other clinical signs and symptoms Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials Permanent dermal filler injected below the subnasale Semi-permanent dermal filler or fat injected below the subnasale within 36 months before enrollment Temporary dermal filler injected below the subnasale within 12 months before enrollment Orthodontics procedures within 12 months before enrollment Botulinum toxin treatment in the chin area within 6 months before enrollment Mesotherapy or cosmetic facial procedures (eg, face-lift, brow lift, facial reconstructive surgery, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) below the subnasale within 6 months before enrollment Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment Abnormal and clinically significant results according to the TI or designee, on hematology, clinical chemistry, or urinalysis Females who are pregnant, nursing, or planning a pregnancy during the study Tattoos, piercings or scars that would interfere with study visual assessments and 3D measurements of chin area in the judgment of TI Trauma to the chin or has residual deficiencies, congenital deformities, or scarring which would impact the trial data evaluation in the judgment of TI Menstruation at the time of study intervention (study intervention may be delayed as necessary to accommodate menstrual period cessation) The participant has a condition or is in a situation which, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: JUVÉDERM VOLUX®<br>Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator. | Device: JUVÉDERM VOLUX®<br>* JUVÉDERM VOLUX® injectable gel<br>|
| Other: Control- No treatment<br>No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. | Device: JUVÉDERM VOLUX®<br>* JUVÉDERM VOLUX® injectable gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24 | The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion. | Change from Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24 | The CACRS is a validated 5-point ordinal scale developed by Allergan to grade the severity of chin retrusion. The scale ranges from 0=none to 4=severe. | Week 24 | 
| Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24 | The subject will assess satisfaction using the 10 items on the Satisfaction with Chin FACE-Q. | Week 24 | 
| Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24 | The GAIS is a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Week 24 | 
| Number of patients experiencing one or more treatment emergent adverse events (TEAEs) | The number of patients who experienced one or more TEAEs | Up to week 52 |