An interventional study of High-Dose Oral 35 kDa Hyaluronan (HA35) in Facial Subcutaneous Fullness, Subcutaneous Fat Accumulation and Facial Inflammatory Erythema, sponsored by Nakhia Impex LLC. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Nakhia Impex LLC · Not applicable, Interventional, and Supportive care
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.
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.
657 studies on the registry are indexed under Body Weight; 76 are open to participants now.
This study's enrollment of 30 is below the median of 71 across 500 interventional studies indexed under Body Weight.
Browse Body Weight studies →Nakhia Impex LLC is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
Time frame: Baseline to Day 40
Change in Body Subcutaneous Fullness Severity (0-10 VAS Score)
Change in body subcutaneous fullness severity, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no fullness and 10 = maximum perceived subcutaneous fullness.
Time frame: Baseline to Day 40
Change in Facial Inflammatory Erythema Severity (0-10 VAS Score)
Change in facial inflammatory erythema severity, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no erythema and 10 = maximum redness.
Time frame: Baseline to Day 7 and Day 40
Change in Facial Vitality (0-10 VAS Score)
Change in perceived facial vitality and skin radiance, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = dull/lifeless and 10 = vibrant/healthy appearance.
Time frame: Baseline to Day 7 and Day 40
Change in body weight (kg)
Change in body weight measured in kilograms (kg) using a calibrated digital scale, taken at the same time of day under consistent conditions.
Time frame: Baseline to Day 40
Incidence and Severity of Treatment-Related Adverse Events
Number and severity of adverse events reported during the study, including gastrointestinal discomfort, allergic reactions, or other systemic effects. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: From baseline to the end of the 40-day intervention period
Gastrointestinal Tolerability (0-10 VAS Score)
Subject-reported gastrointestinal tolerability, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no discomfort and 10 = severe gastrointestinal distress (e.g., bloating, nausea).
Time frame: From baseline to the end of the 40-day intervention period
Ran from May 2026 to primary completion in Jun 2026, 1 month.
Of 226 interventional studies with no phase under Body Weight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 38. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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