JUVÉDERM VOLUX® for Chin Retrusion in China

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.


Eligibility Criteria:
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