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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral 35 kDa Hyaluronan (HA35) Intervention Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Oral 35 kDa Hyaluronan (HA35) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Facial Subcutaneous Fullness VAS Score (0-10) | Change in cheek fullness and double chin prominence measured by 0-10 VAS, 0 = no improvement, 10 = maximum improvement. | Baseline to Day 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Subcutaneous Fullness Severity (0-10 VAS Score) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
| Change in Facial Vitality (0-10 VAS Score) | 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. | Baseline to Day 7 and Day 40 |
| Change in body weight (kg) | Change in body weight measured in kilograms (kg) using a calibrated digital scale, taken at the same time of day under consistent conditions. | Baseline to Day 40 |
| Incidence and Severity of Treatment-Related Adverse Events | 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). | From baseline to the end of the 40-day intervention period |
| Gastrointestinal Tolerability (0-10 VAS Score) | 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 |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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