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

NCT06387212 | Recruiting

• 1 other identifier: HUI0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Inflammation; Cosmetic Skin

Keywords

whitening; pore size; skin dryness; erythema; skin hardness

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  120 minutes and 960 minutes

Secondary Outcomes (1)

• Self-satisfaction evaluation

  1 week after the end of the treatment

Study Arms (1)

DermaShine PRO negative microneedles instrument

EXPERIMENTAL

Drug: 35 kDa hyaluronan fragment HA35 injection

Interventions

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 ).

Also known as: HA35

DermaShine PRO negative microneedles instrument

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。

You may not qualify if:

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

Sponsors & Collaborators

• Nakhia Impex LLC: lead

Study Sites (1)

Nahia Impex LLC

Ulaanbaatar, Mongolia

RECRUITING

MeSH Terms

Conditions

Dermatitis; Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mizhou Hui

CONTACT

13484005199; mizhou.hui@alumni.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 26, 2024
• Study Start: April 15, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)