Skin InflammationNCT06387212
35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Inflammation of Skin
A study testing 35 kDa hyaluronan fragment HA35 injection in people with Skin Inflammation and Cosmetic Skin, run by Nakhia Impex LLC at 1 site in Mongolia.
Trial summary
To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Inflammation, Cosmetic Skin
- What is being tested?
- 35 kDa hyaluronan fragment HA35 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMongolia
- Study dates
- 15 Apr 2024to 22 Jun 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Skin problems include but are not limited to dry skin, dark skin, and coarse pores.
- Chronic skin inflammation, pigmentation, erythema, etc.
- Cooperate with the experimental requirements and be able to complete the score independently。
Who cannot join
- Pregnant or lactating women.
- Suffering from psychological or mental illness.
- Life is not regular, overeating.
- Hypersensitive to hyaluronic acid, and has a scar constitution.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Skin Inflammation
To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems.
- Conditions
- Skin Inflammation, Cosmetic Skin
- Being tested
- 35 kDa hyaluronan fragment HA35 injection
- Keywords
- whitening, pore size, skin dryness, erythema, skin hardness
- Medical subject headings
- Dermatitis, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35 kDa hyaluronan fragment HA35 injectionDrug
Also called HA35
First, apply an appropriate amount of compound lidocaine cream to the treatment site ( national drug approval number H20063466 ; Beijing Ziguang Pharmaceutical Co., Ltd. ) waited for 60 minutes after applying hemp, and then injected the syringe containing sterile HA35 prepared in advance into the subcutaneous 1.0-1.5mm through the DermaShine PRO negative pressure microneedle importer ( Demasha, South Korea ).
| Study group | Role | What they receive |
|---|---|---|
| DermaShine PRO negative microneedles instrument | Experimental | Not described Receives: Drug: 35 kDa hyaluronan fragment HA35 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
A skin dryness scale
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents no skin dryness, while 10 represents the worst degree of skin dryness.
Measured: 120 minutes and 960 minutes
A fair or smooth skin scale
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the worse degree of fair or smooth skin, while 10 represents the best degree of fair or smooth skin.
Measured: 120 minutes and 960 minutes
A skin pore size scale
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of skin pore size, while 10 represents the worst degree of skin pore size.
Measured: 120 minutes and 960 minutes
A inflammatory skin thick hardness scale
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of inflammatory skin thick hardness, while 10 represents the worst degree of inflammatory skin thick hardness.
Measured: 120 minutes and 960 minutes
An erythema color and area scale
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of erythema color and area, while 10 represents the worst degree of erythema color and area scale.
Measured: 120 minutes and 960 minutes
Secondary outcomes (1)
Self-satisfaction evaluation
One week after the end of the treatment, a return visit was conducted to collect the overall satisfaction score of the subjects on the skin treatment. Using the questionnaire (0-10 score) to assess this outcome measure. 0 represents the most dissatisfied, while 10 represents the most satisfied.
Measured: 1 week after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start15 Apr 2024
- Primary completion12 May 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06387212
- Sponsor's protocol ID
- HUI0001
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- 35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Skin Inflammation
- ClinicalTrials.gov ID
- NCT06387212
- Acronym / sponsor ID
- HUI0001
- Conditions
- Skin Inflammation, Cosmetic Skin
- Keywords
- whitening, pore size, skin dryness, erythema, skin hardness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 12 May 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 26 Apr 2024 (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.
To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DermaShine PRO negative microneedles instrument | Experimental | Drug: 35 kDa hyaluronan fragment HA35 injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Skin problems include but are not limited to dry skin, dark skin, and coarse pores.
- Chronic skin inflammation, pigmentation, erythema, etc.
- Cooperate with the experimental requirements and be able to complete the score independently。
Key exclusion criteria (4 listed)
- Pregnant or lactating women.
- Suffering from psychological or mental illness.
- Life is not regular, overeating.
- Hypersensitive to hyaluronic acid, and has a scar constitution.
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 |
|---|---|---|
| 35 kDa hyaluronan fragment HA35 injectionAlso: HA35First, apply an appropriate amount of compound lidocaine cream to the treatment site ( national drug approval number H20063466 ; Beijing Ziguang Pharmaceutical Co., Ltd. ) waited for 60 minutes after applying hemp, and then injected the syringe containing sterile HA35 prepared in advance into the subcutaneous 1.0-1.5mm through the DermaShine PRO negative pressure microneedle importer ( Demasha, South Korea ). | Drug | DermaShine PRO negative microneedles instrument |
Primary outcome
A skin dryness scale
Time frame: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents no skin dryness, while 10 represents the worst degree of skin dryness.
A fair or smooth skin scale
Time frame: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the worse degree of fair or smooth skin, while 10 represents the best degree of fair or smooth skin.
A skin pore size scale
Time frame: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of skin pore size, while 10 represents the worst degree of skin pore size.
A inflammatory skin thick hardness scale
Time frame: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of inflammatory skin thick hardness, while 10 represents the worst degree of inflammatory skin thick hardness.
An erythema color and area scale
Time frame: 120 minutes and 960 minutes
The Numerical Rating Scale (NRS) was revised and improved, and the 10-point digital score was used to allow the subjects to self-evaluate the skin effect before and after treatment for 120 minutes and 960 minutes. 0 represents the best degree of erythema color and area, while 10 represents the worst degree of erythema color and area scale.
1 secondary outcome
Self-satisfaction evaluation
Time frame: 1 week after the end of the treatment
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.
- Individual participant dataSharing planned: No
Related trials for Skin Inflammation
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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 35 kDa hyaluronan fragment HA35 injection in people with Skin Inflammation and Cosmetic Skin, run by Nakhia Impex LLC at 1 site in Mongolia.
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 3 inclusion and 4 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 Mongolia. 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?
A skin dryness scale (time frame: 120 minutes and 960 minutes). The study lists 5 primary outcomes in all. 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.