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CompletedNCT06387212Updated Sep 23, 2026

35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Inflammation of Skin

An interventional study of 35 kDa hyaluronan fragment HA35 injection in Skin Inflammation and Cosmetic Skin, sponsored by Nakhia Impex LLC. Completed at 1 site in Mongolia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Nakhia Impex LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Inflammation
  • Cosmetic Skin

Keywords

  • whitening
  • pore size
  • skin dryness
  • erythema
  • skin hardness
03

In context

Dermatitis

238 studies on the registry are indexed under Dermatitis; 34 are open to participants now.

This study's enrollment of 20 is below the median of 68 across 191 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Nakhia Impex LLC is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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。

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women.
  • Suffering from psychological or mental illness.
  • Life is not regular, overeating.
  • Hypersensitive to hyaluronic acid, and has a scar constitution.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    DermaShine PRO negative microneedles instrument

    Drug: 35 kDa hyaluronan fragment HA35 injection

Interventions

  • 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 ).

    Also known as: HA35

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 120 minutes and 960 minutes

  2. 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.

    Time frame: 120 minutes and 960 minutes

  3. 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.

    Time frame: 120 minutes and 960 minutes

  4. 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.

    Time frame: 120 minutes and 960 minutes

  5. 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.

    Time frame: 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.

    Time frame: 1 week after the end of the treatment

07

Study locations

1 site
  • Nahia Impex LLC
    Ulaanbaatar, Mongolia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06387212
Lead sponsor
Nakhia Impex LLC
Responsible party
Sponsor
First posted
Apr 26, 2024
Start date
Apr 15, 2024
Primary completion
May 12, 2024
Completion
Jun 22, 2024
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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