Clinical trial NCT04559984: JUVÉDERM VOLUX® for Chin Retrusion in China
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chin Retrusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Primary outcomes:
measure: Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
timeFrame: Change from Baseline to Week 24
Secondary outcomes:
measure: China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24
timeFrame: Week 24
measure: Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
timeFrame: Up to week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 224441
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital /ID# 224440
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 224442
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224444
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 224439
state: Jiangsu
city: Beijing
country: China
facility: Peking University International Hospital /ID# 224438
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 224445
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: