Facial Aesthetic Improvement, Facial Erythema, Facial Subcutaneous Fat, Nasal Alar Pore Enlargement, Skin Dullness
Conditions
Keywords
Hyaluronan, 35 kDa Hyaluronan, HA35, Overnight Occlusive, Topical Gel, Facial Fat, Facial Erythema, Skin Radiance, Pore Improvement, Non-invasive Aesthetic, Pilot Clinical Study
Brief summary
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.
Detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of overnight occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving multiple facial aesthetic outcomes, including subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore condition. Eligible subjects will apply HA35 gel to the entire face before sleep, covered with an occlusive film to retain moisture, and left in place overnight. The intervention will be administered once every 2 days for 5 applications over 10 days. Outcomes will be assessed at baseline, after 1 application, and after 5 applications using a standardized 0-10 Numeric Rating Scale (NRS) for subcutaneous fat thickness, erythema severity, skin radiance, and pore enlargement. Local skin tolerability and adverse events will be monitored throughout the study. This is a non-invasive, non-pharmacological aesthetic intervention with minimal risk. All procedures are conducted in accordance with the Declaration of Helsinki, and written informed consent is obtained from all subjects prior to enrollment.
Interventions
DEVICE10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel
A 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.
Sponsors
Nakhia Impex LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Ability to complete self-assessments * Signed written informed consent
Exclusion criteria
* 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 * Severe systemic disease or uncontrolled medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Subcutaneous Fat Thickness NRS Score (0-10) | Baseline to after 1 application and after 5 applications | Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Facial Inflammatory Erythema Severity (0-10 NRS Score) | Baseline (Day 0) to Day 2 and Day 10 | 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) | Baseline (Day 0) to Day 2 and Day 10 | 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) | Baseline (Day 0) to Day 2 and Day 10 | 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 | Baseline (Day 0) to Day 2 and Day 10 | 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). |
Outcome results
None listed