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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNakhia Impex LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • High-Dose Oral 35 kDa Hyaluronan (HA35)

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators