Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement (HA35-ORAL)

Nakhia Impex

Status: Not yet enrolling

Conditions: Facial Vitality Impairment; Body Weight Management; Dull Skin; Facial Subcutaneous Fullness; Facial Inflammatory Erythema; Subcutaneous Fat Accumulation

Treatments: Device: High-Dose Oral 35 kDa Hyaluronan (HA35)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07583108

HA35202604

Details and patient eligibility

About

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.

Full description

This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of high-dose oral 35 kDa hyaluronan (HA35) for improving facial contour, reducing subcutaneous fullness, alleviating inflammatory erythema, enhancing facial vitality, and supporting body weight management.

Eligible subjects will take 5 g of oral HA35 once daily in the morning on an empty stomach for 40 consecutive days. Outcome assessments will be performed at baseline, Day 7, Day 14, Day 28, and Day 40 using a validated 0-10 Visual Analog Scale (VAS) to evaluate subcutaneous fat reduction, erythema improvement, facial vitality, and gastrointestinal tolerance. Body weight will be measured at each time point.

Safety evaluations include monitoring of adverse events, gastrointestinal comfort, dry eye symptoms, and overall tolerability.

This is a non-invasive, oral, non-pharmacological intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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
• Signed written informed consent

Exclusion criteria

• 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
• Pregnant or lactating women
• Participation in another clinical trial within 30 days

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Oral 35 kDa Hyaluronan (HA35) Intervention Group

Experimental group

Description:

Participants receive 5 g of high-dose oral 35 kDa hyaluronan (HA35) once daily on an empty stomach for 40 consecutive days. Efficacy on facial/body fat, erythema, vitality, weight, and safety will be evaluated.

Treatment:

Device: High-Dose Oral 35 kDa Hyaluronan (HA35)