About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel