This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of overnight occlusive topical application of 10% high-concentration 35 kDa hyaluronan (HA35) gel for facial aesthetic improvement. Eligible participants will receive overnight occlusive application once every 2 days for a total of 5 treatments over 10 days. The primary objectives are to assess changes in facial subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore enlargement after 1 and 5 applications. Safety and local tolerability will be evaluated throughout the study period. This is a minimal-risk, non-pharmacological, non-invasive aesthetic intervention.
Age 18-60 years, male or female
Seeking non-invasive improvement of facial appearance
Presenting with at least one of: facial subcutaneous fat accumulation, facial erythema, skin dullness, nasal alar pore enlargement
Baseline NRS score ≥2 for at least one target parameter
Facial aesthetic treatments (injection, laser, fat reduction, peeling) within 2 weeks
Active facial dermatitis, infection, or open wounds
Known hypersensitivity to hyaluronan or gel components
Pregnant or lactating women
Single group
10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel
DeviceA topical, non-pharmacological facial gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied under occlusive conditions overnight to improve facial subcutaneous fat appearance, reduce erythema, enhance radiance, and improve pore condition.
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
Change in facial inflammatory erythema severity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no redness and 10 = maximum facial redness and inflammation.
Change in Facial Skin Radiance (0-10 NRS Score)
Change in perceived facial skin radiance and brightness, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = dull/lifeless skin and 10 = bright, glowing skin.
Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)
Change in the severity of nasal alar pore enlargement, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no visible pores and 10 = maximum pore size and visibility.
Incidence and Severity of Local Skin Adverse Events
Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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