Efficacy and Safety of Overnight Occlusive HA35 Gel for Facial Aesthetic Improvement (HA35-FACIAL)

Nakhia Impex

Status: Not yet enrolling

Conditions: Skin Dullness; Facial Subcutaneous Fat; Facial Aesthetic Improvement; Nasal Alar Pore Enlargement; Facial Erythema

Treatments: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07584811

HA35202603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

HA35 Overnight Occlusive Topical Gel Group

Experimental group

Description:

Participants receive 10% high-concentration 35 kDa HA35 gel as overnight occlusive topical application to the entire face, once every 2 days for 5 applications over 10 days. Efficacy on facial fat, erythema, radiance, pores, and safety will be evaluated.

Treatment:

Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel