Post-marketing Clinical Investigation to Evaluate the Efficacy and Safety of BtHCROSS for Restoring Facial Volume and Filling Facial Folds and Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Determine the BtHCROSS' efficacy in improving the facial volume loss
研究概览
简要总结
This clinical study investigated the safety and effectiveness of BtHCROSS, a hyaluronic acid-based injectable used to restore facial volume and reduce wrinkles. Adults aged 30 to 70 received a single treatment and were monitored over 9 months. Researchers assessed improvements in facial appearance and recorded any side effects. The results aimed to support the product's continued safe use in aesthetic treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 30 and 70 years.
- •Individuals showing mild to moderate signs of facial skin aging (such as loss of brightness, hydration, and/or firmness).
- •Sufficient willingness and ability, as judged by the investigator, to complete the study questionnaires.
排除标准
- •Pregnant or breastfeeding women.
- •Known allergy or sensitivity to hyaluronic acid or any other ingredient in the product.
- •Individuals who have undergone any wrinkle correction or rejuvenation procedures in the past 6 months or during the study (e.g., radiofrequency, electrotherapy, botulinum toxin, thread lifts, or laser techniques).
- •Autoimmune or inflammatory diseases, or any condition affecting skin health that could interfere with the treatment.
- •History of any illness or infection in the injection area during the study.
- •Lymphatic and/or vascular disorders.
- •Individuals with unrealistic expectations about the treatment outcomes.
- •Previous facial surgery.
- •Active infection in the treatment area.
- •Blood coagulation disorders. Subjects on anticoagulant therapy are excluded, even without a diagnosed coagulation issue, unless cleared by their prescribing specialist.
- •Subjects with unrealistic expectations regarding the likely outcomes of the treatment.
结局指标
主要结局
Determine the BtHCROSS' efficacy in improving the facial volume loss
时间窗: 6 months
To determine how effective BtHCROSS is in improving volume loss in the mid-face region comparing the skin's condition before and after treatment. This evaluation is carried out by medical professionals using validated aesthetic scales, depending on the specific product model. The measurements were done using the MFVLS (Mid-Face Volume Loss Scale) a 0-5 scale, 0 being good outcome and 5 being the worst outcome.
Determine the BtHCROSS' efficacy in improving facial wrinkle severity
时间窗: 6 months
To determine how effective BtHCROSS is in improving wrinkle severity comparing the skin's condition before and after treatment. This evaluation is carried out by medical professionals using validated aesthetic scales, depending on the specific product model. The measurements were done using the WSRS(Wrinkle Severity Rating Scale) a 0-5 scale, 0 being good outcome and 5 being the worst outcome.
Determine the BtHCROSS' efficacy in improving lip fullness
时间窗: 6 months
To determine how effective BtHCROSS is in improving vlip fullness comparing the lips's condition before and after treatment. This evaluation is carried out by medical professionals using validated aesthetic scales, depending on the specific product model. The measurements were done using the LFGS (Lip Fullness Grading Scale) a 0-5 scale, 0 being good outcome and 5 being the worst outcome.
Safety Outcome
时间窗: 9 months
The study evaluates the safety of BtHCROSS by systematically recording and analyzing any serious adverse events that occur during the treatment period.
次要结局
- Exploratory objective - Global Aesthetic Improvement Scale (GAIS) by investigator(6-9 months)
- Exploratory objective - Subjective self assessment of the treatment by the patient(6-9 months)