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.
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
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
Single group
High-Dose Oral 35 kDa Hyaluronan (HA35)
DeviceOral 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.
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.
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.
Change in Facial Inflammatory Erythema Severity (0-10 VAS Score)
Change in facial inflammatory erythema severity, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no erythema and 10 = maximum redness.
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.
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.
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