Facial Subcutaneous FatHA35-FACIALNCT07584811
Efficacy and Safety of Overnight Occlusive HA35 Gel for Facial Aesthetic Improvement
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel in people with Facial Subcutaneous Fat and Facial Erythema, 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 overnight occlusive topical application of 10% high-concentration 35 kDa hyaluronan (HA35) gel for facial aesthetic improvement. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Facial Subcutaneous Fat, Facial Erythema, Skin Dullness
- What is being tested?
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel
- Type of treatment
- 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
- 1 May 2026to 20 Aug 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years, male or female
- Seeking non-invasive improvement of facial appearance
- Presenting with at least one of: facial subcutaneous fat accumulation, facial erythema, skin dullness, nasal alar pore enlargement
- Baseline NRS score ≥2 for at least one target parameter
- Ability to complete self-assessments
- Signed written informed consent
Who cannot join
- Facial aesthetic treatments (injection, laser, fat reduction, peeling) within 2 weeks
- Active facial dermatitis, infection, or open wounds
- Known hypersensitivity to hyaluronan or gel components
- Pregnant or lactating women
- Severe systemic disease or uncontrolled medical condition
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 Overnight Occlusive Topical 10% 35 kDa Hyaluronan (HA35) Gel for Facial Subcutaneous Fat Appearance, Erythema, Skin Radiance, and Pore Condition
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of overnight occlusive topical application of 10% high-concentration 35 kDa hyaluronan (HA35) gel for facial aesthetic improvement. Eligible participants will receive overnight occlusive application once every 2 days for a total of 5 treatments over 10 days. The primary objectives are to assess changes in facial subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore enlargement after 1 and 5 applications. Safety and local tolerability will be evaluated throughout the study period. This is a minimal-risk, non-pharmacological, non-invasive aesthetic intervention.
Read the detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of overnight occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving multiple facial aesthetic outcomes, including subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore condition.
Eligible subjects will apply HA35 gel to the entire face before sleep, covered with an occlusive film to retain moisture, and left in place overnight. The intervention will be administered once every 2 days for 5 applications over 10 days.
Outcomes will be assessed at baseline, after 1 application, and after 5 applications using a standardized 0-10 Numeric Rating Scale (NRS) for subcutaneous fat thickness, erythema severity, skin radiance, and pore enlargement. Local skin tolerability and adverse events will be monitored throughout the study.
This is a non-invasive, non-pharmacological aesthetic intervention with minimal risk. All procedures are conducted in accordance with the Declaration of Helsinki, and written informed consent is obtained from all subjects prior to enrollment.
- Conditions
- Facial Subcutaneous Fat, Facial Erythema, Skin Dullness, Nasal Alar Pore Enlargement, Facial Aesthetic Improvement
- Being tested
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Overnight Occlusive, Topical Gel, Facial Fat, Facial Erythema, Skin Radiance, Pore Improvement, Non-invasive Aesthetic, Pilot Clinical Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive GelDevice
Also called HA35 Facial Aesthetic Gel, Overnight HA35 Gel
A topical, non-pharmacological facial gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied under occlusive conditions overnight to improve facial subcutaneous fat appearance, reduce erythema, enhance radiance, and improve pore condition.
| Study group | Role | What they receive |
|---|---|---|
| HA35 Overnight Occlusive Topical Gel Group | Experimental | Participants receive 10% high-concentration 35 kDa HA35 gel as overnight occlusive topical application to the entire face, once every 2 days for 5 applications over 10 days. Efficacy on facial fat, erythema, radiance, pores, and safety will be evaluated. Receives: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
Measured: Baseline to after 1 application and after 5 applications
Secondary outcomes (5)
Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
Change in facial inflammatory erythema severity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no redness and 10 = maximum facial redness and inflammation.
Measured: Baseline (Day 0) to Day 2 and Day 10
Change in Facial Skin Radiance (0-10 NRS Score)
Change in perceived facial skin radiance and brightness, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = dull/lifeless skin and 10 = bright, glowing skin.
Measured: Baseline (Day 0) to Day 2 and Day 10
Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)
Change in the severity of nasal alar pore enlargement, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no visible pores and 10 = maximum pore size and visibility.
Measured: Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From Day 0 to Day 10
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 start1 May 2026
- Primary completion20 Jun 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Subcutaneous FatStudies 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
- NCT07584811
- Sponsor's protocol ID
- HA35202603
- Acronym
- HA35-FACIAL
- 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 Overnight Occlusive Topical 10% 35 kDa Hyaluronan (HA35) Gel for Facial Subcutaneous Fat Appearance, Erythema, Skin Radiance, and Pore Condition
- ClinicalTrials.gov ID
- NCT07584811
- Acronym / sponsor ID
- HA35-FACIAL / HA35202603
- Conditions
- Facial Subcutaneous Fat, Facial Erythema, Skin Dullness, Nasal Alar Pore Enlargement, Facial Aesthetic Improvement
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Overnight Occlusive, Topical Gel, Facial Fat, Facial Erythema, Skin Radiance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Aug 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 overnight occlusive topical application of 10% high-concentration 35 kDa hyaluronan (HA35) gel for facial aesthetic improvement. Eligible participants will receive overnight occlusive application once every 2 days for a total of 5 treatments over 10 days. The primary objectives are to assess changes in facial subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore enlargement after 1 and 5 applications. Safety and local tolerability will be evaluated throughout the study period. This is a minimal-risk, non-pharmacological, non-invasive aesthetic intervention.
Detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of overnight occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving multiple facial aesthetic outcomes, including subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore condition.
Eligible subjects will apply HA35 gel to the entire face before sleep, covered with an occlusive film to retain moisture, and left in place overnight. The intervention will be administered once every 2 days for 5 applications over 10 days.
Outcomes will be assessed at baseline, after 1 application, and after 5 applications using a standardized 0-10 Numeric Rating Scale (NRS) for subcutaneous fat thickness, erythema severity, skin radiance, and pore enlargement. Local skin tolerability and adverse events will be monitored throughout the study.
This is a non-invasive, non-pharmacological aesthetic intervention with minimal risk. All procedures are conducted in accordance with the Declaration of Helsinki, and written informed consent is 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 |
|---|---|---|
| HA35 Overnight Occlusive Topical Gel Group | Experimental | Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive GelParticipants receive 10% high-concentration 35 kDa HA35 gel as overnight occlusive topical application to the entire face, once every 2 days for 5 applications over 10 days. Efficacy on facial fat, erythema, radiance, pores, and safety will be evaluated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years, male or female
- Seeking non-invasive improvement of facial appearance
- Presenting with at least one of: facial subcutaneous fat accumulation, facial erythema, skin dullness, nasal alar pore enlargement
- Baseline NRS score ≥2 for at least one target parameter
- Ability to complete self-assessments
Key exclusion criteria (5 listed)
- Facial aesthetic treatments (injection, laser, fat reduction, peeling) within 2 weeks
- Active facial dermatitis, infection, or open wounds
- Known hypersensitivity to hyaluronan or gel components
- Pregnant or lactating women
- Severe systemic disease or uncontrolled medical condition
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 |
|---|---|---|
| 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive GelAlso: HA35 Facial Aesthetic Gel, Overnight HA35 GelA topical, non-pharmacological facial gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied under occlusive conditions overnight to improve facial subcutaneous fat appearance, reduce erythema, enhance radiance, and improve pore condition. | Device | HA35 Overnight Occlusive Topical Gel Group |
Primary outcome
Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
Time frame: Baseline to after 1 application and after 5 applications
Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
5 secondary outcomes
Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
Time frame: Baseline (Day 0) to Day 2 and Day 10
Change in Facial Skin Radiance (0-10 NRS Score)
Time frame: Baseline (Day 0) to Day 2 and Day 10
Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)
Time frame: Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
Time frame: Baseline (Day 0) to Day 2 and Day 10
Incidence and Severity of Local Skin Adverse Events
Time frame: From Day 0 to Day 10
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.
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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 10% High-Concentration 35 kDa Hyaluronan (HA35) Facial Occlusive Gel in people with Facial Subcutaneous Fat and Facial Erythema, 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 6 inclusion and 5 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 Fat Thickness NRS Score (0-10) (time frame: Baseline to after 1 application and after 5 applications). 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.