Facial Subcutaneous FullnessHA35-ORALNCT07583108
Efficacy and Safety of High-Dose Oral 35 kDa Hyaluronan for Aesthetic Improvement
A study testing High-Dose Oral 35 kDa Hyaluronan (HA35) in people with Facial Subcutaneous Fullness and Subcutaneous Fat Accumulation, run by Nakhia Impex LLC at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Subcutaneous Fullness, Subcutaneous Fat Accumulation, Facial Inflammatory Erythema
- What is being tested?
- High-Dose Oral 35 kDa Hyaluronan (HA35)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Facial Subcutaneous Fullness, Subcutaneous Fat Accumulation, Facial Inflammatory Erythema, Dull Skin, Facial Vitality Impairment, Body Weight Management
- Being tested
- High-Dose Oral 35 kDa Hyaluronan (HA35)
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Oral Administration, Subcutaneous Fat Reduction, Facial Erythema, Facial Vitality, Body Weight, Non-invasive Aesthetic, Pilot Clinical Study
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Oral 35 kDa Hyaluronan (HA35)Device
Also called Oral HA35, 35 kDa Hyaluronan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High-Dose Oral 35 kDa Hyaluronan (HA35) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 40
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: From baseline to the end of the 40-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start20 May 2026
- Primary completion20 Jun 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Subcutaneous FullnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583108
- Sponsor's protocol ID
- HA35202604
- Acronym
- HA35-ORAL
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07583108
- Acronym / sponsor ID
- HA35-ORAL / HA35202604
- Conditions
- Facial Subcutaneous Fullness, Subcutaneous Fat Accumulation, Facial Inflammatory Erythema, Dull Skin, Facial Vitality Impairment, Body Weight Management
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Oral Administration, Subcutaneous Fat Reduction, Facial Erythema, Facial Vitality, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral 35 kDa Hyaluronan (HA35) Intervention Group | Experimental | Device: High-Dose Oral 35 kDa Hyaluronan (HA35)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Dose Oral 35 kDa Hyaluronan (HA35)Also: Oral HA35, 35 kDa HyaluronanOral 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. | Device | Oral 35 kDa Hyaluronan (HA35) Intervention Group |
Primary outcome
Change in Facial Subcutaneous Fullness VAS Score (0-10)
Time frame: Baseline to Day 40
Change in cheek fullness and double chin prominence measured by 0-10 VAS, 0 = no improvement, 10 = maximum improvement.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Dose Oral 35 kDa Hyaluronan (HA35) in people with Facial Subcutaneous Fullness and Subcutaneous Fat Accumulation, run by Nakhia Impex LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Facial Subcutaneous Fullness VAS Score (0-10) (time frame: Baseline to Day 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.