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Not yet recruiting NCT07583108

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

No phase Interventional Facial Subcutaneous Fullness Subcutaneous Fat Accumulation Facial Inflammatory Erythema Dull Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Dose Oral 35 kDa Hyaluronan (HA35).
Who it may be relevant to
Registry conditions: Facial Subcutaneous Fullness, Subcutaneous Fat Accumulation, Facial Inflammatory Erythema, Dull Skin. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan (HA35) in Subjects Seeking Facial and Body Aesthetic Improvement

Overview

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.

Detailed 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.

Interventions

  • Device High-Dose Oral 35 kDa Hyaluronan (HA35)
    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.

Primary outcome measures

  • Change in Facial Subcutaneous Fullness VAS Score (0-10) [Time frame: Baseline to Day 40]
Secondary outcome measures (6)
  • Change in Body Subcutaneous Fullness Severity (0-10 VAS Score) [Time frame: Baseline to Day 40]
  • Change in Facial Inflammatory Erythema Severity (0-10 VAS Score) [Time frame: Baseline to Day 7 and Day 40]
  • Change in Facial Vitality (0-10 VAS Score) [Time frame: Baseline to Day 7 and Day 40]
  • Change in body weight (kg) [Time frame: Baseline to Day 40]
  • Incidence and Severity of Treatment-Related Adverse Events [Time frame: From baseline to the end of the 40-day intervention period]
  • Gastrointestinal Tolerability (0-10 VAS Score) [Time frame: From baseline to the end of the 40-day intervention period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07583108 · HA35202604

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗