A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan (HA35) in Subjects Seeking Facial and Body Aesthetic Improvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Facial Subcutaneous Fullness VAS Score (0-10)
研究概览
简要总结
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of high-dose oral 70 kDa hyaluronan (HA35) for aesthetic improvement. Eligible participants will receive 5 g oral HA35 once daily on an empty stomach for 40 consecutive days. The primary objectives are to assess changes in facial and body subcutaneous fullness, inflammatory erythema, facial vitality, and body weight. Safety, gastrointestinal tolerability, and additional exploratory outcomes will be evaluated throughout the intervention period. This is a minimal-risk, oral, non-pharmacological supportive care intervention.
详细描述
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of high-dose oral 35 kDa hyaluronan (HA35) for improving facial contour, reducing subcutaneous fullness, alleviating inflammatory erythema, enhancing facial vitality, and supporting body weight management.
Eligible subjects will take 5 g of oral HA35 once daily in the morning on an empty stomach for 40 consecutive days. Outcome assessments will be performed at baseline, Day 7, Day 14, Day 28, and Day 40 using a validated 0-10 Visual Analog Scale (VAS) to evaluate subcutaneous fat reduction, erythema improvement, facial vitality, and gastrointestinal tolerance. Body weight will be measured at each time point.
Safety evaluations include monitoring of adverse events, gastrointestinal comfort, dry eye symptoms, and overall tolerability.
This is a non-invasive, oral, non-pharmacological intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years, male or female
- •Seeking non-invasive improvement of facial/body appearance
- •Presenting with facial fullness, double chin, subcutaneous fat accumulation, facial erythema, or dull skin
- •Ability to complete VAS assessments and study logs
- •Signed written informed consent
排除标准
- •Aesthetic/weight loss treatments (injection, laser, liposuction, diet drugs) within 4 weeks
- •Significant weight change (>3 kg) within 3 months
- •Uncontrolled systemic disease (diabetes, hypertension, etc.)
- •Known hypersensitivity to hyaluronan
- •Pregnant or lactating women
- •Participation in another clinical trial within 30 days
研究组 & 干预措施
Oral 35 kDa Hyaluronan (HA35) Intervention Group
Participants receive 5 g of high-dose oral 35 kDa hyaluronan (HA35) once daily on an empty stomach for 40 consecutive days. Efficacy on facial/body fat, erythema, vitality, weight, and safety will be evaluated.
干预措施: High-Dose Oral 35 kDa Hyaluronan (HA35) (Device)
结局指标
主要结局
Change in Facial Subcutaneous Fullness VAS Score (0-10)
时间窗: Baseline to Day 40
Change in cheek fullness and double chin prominence measured by 0-10 VAS, 0 = no improvement, 10 = maximum improvement.
次要结局
- Change in Facial Vitality (0-10 VAS Score)(Baseline to Day 7 and Day 40)
- Change in body weight (kg)(Baseline to Day 40)
- Incidence and Severity of Treatment-Related Adverse Events(From baseline to the end of the 40-day intervention period)
- Change in Body Subcutaneous Fullness Severity (0-10 VAS Score)(Baseline to Day 40)
- Change in Facial Inflammatory Erythema Severity (0-10 VAS Score)(Baseline to Day 7 and Day 40)
- Gastrointestinal Tolerability (0-10 VAS Score)(From baseline to the end of the 40-day intervention period)