Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement (HA35-ORAL)
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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
Oral powder formulation containing high-purity35 kDa hyaluronan fragments (20-80 kDa), 5 g per day, administered orally on an empty stomach for 40 days to improve facial contour, reduce subcutaneous fullness, alleviate erythema, and enhance facial vitality.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Facial Subcutaneous Fullness VAS Score (0-10)
大体时间：Baseline to Day 40
|
Change in cheek fullness and double chin prominence measured by 0-10 VAS, 0 = no improvement, 10 = maximum improvement.
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Baseline to Day 40
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Body Subcutaneous Fullness Severity (0-10 VAS Score)
大体时间：Baseline to Day 40
|
Change in body subcutaneous fullness severity, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no fullness and 10 = maximum perceived subcutaneous fullness.
|
Baseline to Day 40
|
|
Change in Facial Inflammatory Erythema Severity (0-10 VAS Score)
大体时间：Baseline to Day 7 and Day 40
|
Change in facial inflammatory erythema severity, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no erythema and 10 = maximum redness.
|
Baseline to Day 7 and Day 40
|
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Change in Facial Vitality (0-10 VAS Score)
大体时间：Baseline to Day 7 and Day 40
|
Change in perceived facial vitality and skin radiance, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = dull/lifeless and 10 = vibrant/healthy appearance.
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Baseline to Day 7 and Day 40
|
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Change in body weight (kg)
大体时间：Baseline to Day 40
|
Change in body weight measured in kilograms (kg) using a calibrated digital scale, taken at the same time of day under consistent conditions.
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Baseline to Day 40
|
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Incidence and Severity of Treatment-Related Adverse Events
大体时间：From baseline to the end of the 40-day intervention period
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Number and severity of adverse events reported during the study, including gastrointestinal discomfort, allergic reactions, or other systemic effects.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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From baseline to the end of the 40-day intervention period
|
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Gastrointestinal Tolerability (0-10 VAS Score)
大体时间：From baseline to the end of the 40-day intervention period
|
Subject-reported gastrointestinal tolerability, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no discomfort and 10 = severe gastrointestinal distress (e.g., bloating, nausea).
|
From baseline to the end of the 40-day intervention period
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- HA35202604
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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