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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Treatment group will receive STYLAGE® XXL at enrollment with an optional touch up injection 30 days later |
|
| control group | Experimental | Control group will not be treated at enrollment visit. Subjects will receive STYLAGE® XXL at visit 6 months after randomization, if they are still eligible for chin augmentation with an optional touch up injection 30 days later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stylage XXL at enrollment | Device | Injection in the chin at enrollment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Glabella-subnasale-pogonion angle change in degrees |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wu | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Dong Cheng District | 100730 | China | ||
| Guangdong Second Provincial General Hospital |
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A no-treatment Controlled, Prospective, Randomized, Multimulti-center, Evaluator-Blinded Study
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The primary hypothesis of this trial will be based on the chin volume change assessed by a central reader blinded to subject treatment
| Stylage XXL at Month 6 |
| Device |
Injection in the chin 6 months after randomization |
|
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 |
| 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. | 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. | 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. | 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) | Day 1 and 1 month |
| Safety : report of AE / SAEs | Adverse Events (AEs) report throughout the study | 1,3,6 months |
| Safety : Vital signs Body temperature | Body temperature will be measured and recorded in degrees Celsius | 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 | 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. | 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) | 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. | 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. | 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.). | 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 | 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 | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation FIB | FIB (Fibrinogene) is measured in g/L | 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 | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation Hepatic function | ALT/AST aminotransferase enzymes are measured in units/L of serum | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation Renal function | BUN (blood urea nitrogen) and plasma creatinine in mg/dL | 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) | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation hematology Hb | Hb (hemoglobin) in g/dL | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation hematology HCT | HCT (hematocrit) in % | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation Hematology PLT | PLT count (platelets/mcL) | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation Urinalysis pH | pH | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation Urinalysis leucocytes | leucocytes in wbc/hpf. | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation Chemical Urinalysis | nitrites, protein, blood, glucose : dispstick urinalysis | Screening, 1 month , 12 months |
| Safety : Clinical Laboratory evaluation Pregnancy testing | β-hCG in urine or serum (mIU/mL) | 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 | Screening, 1 month |
| Guangzhou |
| Guangdong |
| 510317 |
| China |
| Peking University Third Hospital | Beijing | Haidian District | 100191 | China |
| West China Hospital of Stomatology Sichuan University | Chengdu | Sichuan | 610041 | China |
| Peking University First Hospital | Beijing | Xicheng District | 100034 | China |