NCT05009381已完成不适用
A No-treatment Controlled, Prospective, Randomized, Multimulti-center, Evaluator-Blinded Study to Evaluate the Effectiveness and Safety of STYLAGE® XXL for Chin Augmentation in Chinese Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 5
- 主要终点
- Chin volume change in ml
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary hypothesis of this trial will be based on the chin volume change assessed by a central reader blinded to subject treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese ethnicity
- •Subjects seeking for chin volume augmentation
- •Per Investigator's assessment, subjects who require 1 to 4 mL total volume of STYLAGE® XXL for chin augmentation to achieve a meaningful improvement and/or change in their aesthetic appearance.
- •With realistic expectations who can understand and comply with the instructions and all visit schedule.
- •Willing to abstain from other facial cosmetic procedures (e.g., further augmentation therapy, botulinum toxin injections, laser or chemical skin resurfacing, or face lift procedures) below the level of the horizontal line from subnasale for the duration of the study.
- •Women of childbearing potential (WOCBP) who agree contraception during the study period.
- •Subjects who voluntarily decided the participation of the study and signed the informed consent.
- •Being able to stand mild pain.
排除标准
- •Subjects who are contraindicated to injection with HA fillers.
- •Subjects who had a history of keloid formation or hypertrophic scar.
- •Subjects presenting a scar or skin disorder (e.g., active dermal disease [facial psoriasis, eczema, rosacea, perioral dermatitis, acne, herpes, etc], inflammation or an unhealed wound) below the level of the horizontal line from subnasale that may confound the study evaluation.
- •Has ever received permanent (non-biodegradable) or semi-permanent fillers or permanent facial implants (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene), or fat injections below the level of the horizontal line from subnasale, or is planning to be implanted with any of these products at any time during the study.
- •Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) for facial tissue augmentation therapy in the chin and/or lips within 12 months before enrollment or is planning to undergo such treatment during the study
- •Has undergone botulinum toxin injections, mesotherapy, or cosmetic facial procedures (e.g., facial liposuction, aesthetic surgery, face-lift, photomodulation, intense pulsed light, radio frequency, dermabrasion, laser or chemical peel, or other ablative procedures) below the level of the horizontal line from subnasale within 6 months or is planning to undergo any such treatment during the study.
- •Subjects who has any history of severe multiple allergies or an allergy resulting in anaphylaxis, or a hypersensivity to hyaluronic acid and/or one of the ingredients of the study products.
- •Subject is pregnant or planning to be pregnant during the study period or lactating. Women of childbearing potential who have a positive pregnancy test result during screening or at baseline. Women of childbearing potential who are unwilling to use effective birth control measures during the full course of the study.
- •Subject currently suffering from a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk for participation in this clinical trial (e.g., cancer or pre-cancer, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (e.g., stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure [classified as NYHA III-IV], etc.) etc.).
- •Subjects having history of cancer within 5 years
- •Subjects who received oral surgery (e.g., tooth extraction, orthodontia or implantation) or sinus surgery within 6 weeks before enrollment or is planning to undergo any of these procedures during the study.
- •Subject has history or active autoimmune disease (e.g., inflammatory bowel disease), active or history of connective tissue disease (rheumatoid arthritis, scleroderma, and systemic lupus erythematosus)
- •Subjects with current or a history of hemorrhagic diseases.
- •Subjects who received chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g., monoclonal antibodies), systemic corticosteroids within 3 months before treatment (inhaled corticoids are allowed).
- •Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product per Investigator's judgement.
- •Subjects who participated in other clinical trial within 30 days or who is in an exclusion period of one (e.g., in the screening period of another trial).
- •Subjects with hypertension (systolic blood pressure above 160mmHg or diastolic blood pressure above 100 mmHg at resting status), and/or significant liver (serum ALT or AST ≥2X the upper limit of the reference range), kidney (BUN, Urea or Cr≥1.5X the upper limit of the reference range), and/or blood coagulation disorders (PT, APTT or INR >20% of the reference range).
- •Current or a history of alcoholism, drug abuse, or drug dependence
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- •Subject with a past history of streptococcal disease (manifested by recurrent sore throat or acute rheumatic fever) or with an active infection to streptococcus.
- •Has facial hair (e.g., beards, sideburns, etc.), piercing or tattoo in the area to be treated that would interfere with investigation assessments and create inconsistency in required investigation photography during the study period
- •Personnel of the study department, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), employees, or close relatives of employees at the Sponsor or CRO company.
- •Other conditions the Investigator considers inappropriate for enrollment
结局指标
主要结局
Chin volume change in ml
时间窗: 6 months
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.
次要结局
- Safety : Clinical Laboratory evaluation Hematology cells(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation hematology Hb(Screening, 1 month , 12 months)
- Chin volume change in ml(3 months)
- Safety : Physical evaluation BMI(screening and 12 months)
- Safety : Clinical Laboratory evaluation Renal function(Screening, 1 month , 12 months)
- Global Aesthetic Improvement Scale (GAIS) Optimal chin augmentation defined as the best possible aesthetic result assessed by the Treating investigator(1,3 and 6 months)
- Safety : Vital signs Body temperature(Screening, Day 1, 1,3,6,9,12 months)
- Safety : report of AE / SAEs(1,3,6 months)
- Safety : Physical evaluation Visual inspection of the skin(1 month)
- Safety : Clinical Laboratory evaluation Glucose and electrolytes(Screening, 1 month , 12 months)
- Subject satisfaction assessment(1,3 , 6 , 9 , 12 months)
- Safety : Physical evaluation(screening and 12 months)
- Safety : Clinical Laboratory evaluation PT and APTT(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation FIB(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation Hepatic function(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation Urinalysis pH(Screening, 1 month , 12 months)
- Glabella-subnasale-pogonion angle change in degrees(1,3 and 6 months)
- Results of device performance evaluation respectively.(Day 1 and 1 month)
- Safety : Vital signs Heart rate(Screening, Day 1, 1,3,6,9,12 months)
- Safety : Clinical Laboratory evaluation INR(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation Urinalysis leucocytes(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation Chemical Urinalysis(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation Pregnancy testing(Screening, 1 month , 12 months)
- Global Aesthetic Improvement Scale (GAIS) Optimal chin augmentation defined as the best possible aesthetic result assessed by the subject(1,3 and 6 months)
- Safety : Vital signs respiration rate(Screening, Day 1, 1,3,6,9,12 months)
- Safety : Vital signs Blood pressure(Screening, Day 1, 1,3,6,9,12 months)
- Safety : Clinical Laboratory evaluation hematology HCT(Screening, 1 month , 12 months)
- Safety : Clinical Laboratory evaluation Hematology PLT(Screening, 1 month , 12 months)
- Safety : ECG(Screening, 1 month)
研究者
研究点 (5)
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