Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement

NCT07583108 | Not Yet Recruiting

• 1 other identifier: HA35202604
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Oral Administration; Subcutaneous Fat Reduction; Facial Erythema; Facial Vitality; Body Weight; Non-invasive Aesthetic; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• Change in Facial Subcutaneous Fullness VAS Score (0-10)

  Change in cheek fullness and double chin prominence measured by 0-10 VAS, 0 = no improvement, 10 = maximum improvement.

  Baseline to Day 40

Secondary Outcomes (6)

• Change in Body Subcutaneous Fullness Severity (0-10 VAS Score)

  Baseline to Day 40

• Change in Facial Inflammatory Erythema Severity (0-10 VAS Score)

  Baseline to Day 7 and Day 40

• Change in Facial Vitality (0-10 VAS Score)

  Baseline to Day 7 and Day 40

• Change in body weight (kg)

  Baseline to Day 40

• Incidence and Severity of Treatment-Related Adverse Events

  From baseline to the end of the 40-day intervention period

Study Arms (1)

Oral 35 kDa Hyaluronan (HA35) Intervention Group

EXPERIMENTAL

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.

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

Interventions

High-Dose Oral 35 kDa Hyaluronan (HA35) DEVICE

Oral powder formulation containing high-purity35 kDa hyaluronan fragments (20-80 kDa), 5 g per day, administered orally on an empty stomach for 40 days to improve facial contour, reduce subcutaneous fullness, alleviate erythema, and enhance facial vitality.

Also known as: Oral HA35, 35 kDa Hyaluronan

Oral 35 kDa Hyaluronan (HA35) Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nakhia Impex LLC: lead

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04