The aim of this trial is to demonstrate the efficacy and safety of STYLAGE® XXL in augmenting the chin volume among Chinese adults. Subjects will be randomized either to the treatment group or the control group in a 4:1 ratio The superiority of STYLAGE® XXL against no-treatment control in chin volume augmentation will be verified together with assessments of the safety profiles.
This study is a no-treatment controlled, prospective, randomized, multi-center, evaluator-blinded study, in Chinese subjects seeking for chin volume augmentation. 150 subjects will be randomized either to the treatment group or the control group in a 4:1 ratio (120 subjects in the treatment group and 30 subjects in the control group). Subjets assigned to the treatment group will receive STYLAGE® XXL at enrollment. Subjects assigned to the control group will not receive treatment at enrollment; however, at 6 month visit, subjects who are still eligible for chin augmentation with STYLAGE® XXL will be treated STYLAGE® XXL superiority will be demonstrated against no-treatment control in augmenting the chin volume, as measured by blinded evaluator at 6-month
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
174
Injection in the chin at enrollment
Injection in the chin 6 months after randomization
Beijing Hospital
Beijing, Dong Cheng District, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Peking University Third Hospital
Beijing, Haidian District, China
West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, China
Chin volume change in ml
Chin volume change in ml, from baseline to 6 months (after last treatment in the treatment group, and after randomization in the control group) between the treatment and control groups as measured by the blinded evaluator using the 3D system.
Time frame: 6 months
Chin volume change in ml
Chin volume change in ml, from baseline to 1- and 3- months (after last treatment in the treatment group, and after randomization in the control group), respectively, between the treatment and control groups as measured by the blinded evaluator using the 3D system
Time frame: 3 months
Glabella-subnasale-pogonion angle change in degrees
Glabella-subnasale-pogonion angle change in degrees, from baseline to 1-, 3-, and 6- months (after last treatment in the treatment group, and after randomization in the control group), respectively, between the treatment and control groups as measured by the blinded evaluator using the 3D system
Time frame: 1,3 and 6 months
Global Aesthetic Improvement Scale (GAIS) Optimal chin augmentation defined as the best possible aesthetic result assessed by the Treating investigator
Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Treating Investigator assessed Global Aesthetic Improvement Scale (GAIS), at 1-, 3-, and 6- months (after last treatment in the treatment group, and after randomization in the control group), respectively, between the treatment and control groups.
Time frame: 1,3 and 6 months
Global Aesthetic Improvement Scale (GAIS) Optimal chin augmentation defined as the best possible aesthetic result assessed by the subject
Percentage of responders, defined by having "Improved", "Much improved" or "Very much improved" according to the Subject assessed Global Aesthetic Improvement Scale (GAIS), at 1-, 3-, and 6- months (after last treatment in the treatment group, and after randomization in the control group), respectively , between the treatment and control groups.
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Peking University First Hospital
Beijing, Xicheng District, China
Time frame: 1,3 and 6 months
Subject satisfaction assessment
Percentage of satisfied subjects on each question of the subject satisfaction questionnaire The response scale for each question consists of five categories (strongly agree, agree, not sure, disagree, strongly disagree). A subject will be considered as "satisfied" if the answer is "strongly agree" or "agree" in that question.
Time frame: 1,3 , 6 , 9 , 12 months
Results of device performance evaluation respectively.
The Treating Investigator will be asked to rate the: (1) ease of injection, (2) extrusion force, and (3) moldability/malleability on an 11-point numeric scale ranged from 0 (Easy) to 10 (Hard)
Time frame: Day 1 and 1 month
Safety : report of AE / SAEs
Adverse Events (AEs) report throughout the study
Time frame: 1,3,6 months
Safety : Vital signs Body temperature
Body temperature will be measured and recorded in degrees Celsius
Time frame: Screening, Day 1, 1,3,6,9,12 months
Safety : Vital signs Heart rate
Heart rate : Subjects should be seated at rest to measure heart rate . Heart rate measurements should be made by counting heartbeats for a period of 30 seconds and multiplying these values by 2 to obtain the rates per minute
Time frame: Screening, Day 1, 1,3,6,9,12 months
Safety : Vital signs respiration rate
Respiration rate :Subjects should be seated at rest to measure respiratory rate.. Respiration rate will be recorded by counting the number of breath cycles in 1 minute.
Time frame: Screening, Day 1, 1,3,6,9,12 months
Safety : Vital signs Blood pressure
Blood pressure (systolic and diastolic) : Blood pressure will be measured in sitting position at rest using a standardized sphygmomanometer equipped in the site and standardized cuff adapted to the size of the subject's arm. The blood pressure is recorded in millimeters of mercury (mmHg)
Time frame: Screening, Day 1, 1,3,6,9,12 months
Safety : Physical evaluation
The physical evaluation is a test to determine the overall health of the subject. The investigator will inspect the following parts of body : Skin and mucous, lymph nodes, head (eyes, nose, ears, mouth), neck (thyroid, vessels, trachea) , chest (heart, lungs), abdomen (liver, spleen, kidney) , muscle-skeleton and neurologic systems by checking consistency,location, size, tenderness, and texure of the individual organs.
Time frame: screening and 12 months
Safety : Physical evaluation BMI
Height is measured in meter, weight is measured in kg, BMI is calculated in kg/m\^2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Time frame: screening and 12 months
Safety : Physical evaluation Visual inspection of the skin
Visual inspection of the skin in the injection area (e.g., sclerosis, pruritus, pain, reddish, edema, bruises, ecchymosis, infection, inflammation, allergy, and formation of scar and/or granuloma, etc.).
Time frame: 1 month
Safety : Clinical Laboratory evaluation PT and APTT
Blood coagulation: PT(prothrombin time), and APTT (activated partial thromboplastin time) are measured in seconds Urinalysis: pH, leucocytes, nitrites, protein, blood, glucose Pregnancy testing
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation INR
INR (international normalized ratio) is calculated as a ratio of the patient's PT in seconds to a control PT standardized in seconds
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation FIB
FIB (Fibrinogene) is measured in g/L
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Glucose and electrolytes
Blood Glucose and serum electrolytes (Na+、K+、Cl-、Ca2+, Mg2+) are measured in mmol/L
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Hepatic function
ALT/AST aminotransferase enzymes are measured in units/L of serum
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Renal function
BUN (blood urea nitrogen) and plasma creatinine in mg/dL
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Hematology cells
RBC count, WBC count with differential are expressed in cells/ mcL (including absolute WBC count, absolute count and percentage of the 5 WBC differentials including neutrophil, eosinophil, basophil, lymphocyte, and monocyte)
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation hematology Hb
Hb (hemoglobin) in g/dL
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation hematology HCT
HCT (hematocrit) in %
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Hematology PLT
PLT count (platelets/mcL)
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Urinalysis pH
pH
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Urinalysis leucocytes
leucocytes in wbc/hpf.
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Chemical Urinalysis
nitrites, protein, blood, glucose : dispstick urinalysis
Time frame: Screening, 1 month , 12 months
Safety : Clinical Laboratory evaluation Pregnancy testing
β-hCG in urine or serum (mIU/mL)
Time frame: Screening, 1 month , 12 months
Safety : ECG
Standard ECGs (12-Lead ECG or 15 Lead ECG) will be recorded in a supine position at resting status
Time frame: Screening, 1 month