Clinical Efficacy and Safety of 35 kDa Hyaluronan Fragment (HA35) Injection in the Treatment of Skin Problems.

Skin Inflammation Clinical Trial

Official title:

Cosmetic Dermatology and Inflammation of Chronic Skin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387212
• Other study ID #: HUI0001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Nakhia Impex LLC
• Contact: Mizhou Hui
• Phone: 13484005199
• Email: mizhou.hui[@]alumni.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Inflammation
• Skin Inflammation

Intervention

Drug:
• 35 kDa hyaluronan fragment HA35 injection
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 ).

Locations

Country	Name	City	State
Mongolia	Nahia Impex LLC	Ulaanbaatar

Sponsors (1)

Lead Sponsor	Collaborator
Nakhia Impex LLC

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	1 week after the end of the treatment

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