Skip to main content
OpenTrials
Completed

NCT Number: NCT06387212

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

To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Inflammation Cosmetic Skin Dermatitis Erythema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nahia Impex LLC

Ulaanbaatar, Mongolia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

35 kDa hyaluronan fragment HA35 injection

Drug

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 ).

Other names: HA35

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Self-satisfaction evaluation

    Time frame: 1 week after the end of the treatment

    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.

Sponsors and collaborators

Lead sponsor

Nakhia Impex LLC

Industry

Registry information

Official study title

35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Skin Inflammation

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2024
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.