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

Not Applicable

Recruiting

• Conditions: Cosmetic Skin; Skin Inflammation
• Interventions: Drug: 35 kDa hyaluronan fragment HA35 injection

• Registration Number: NCT06387212
• Lead Sponsor: Nakhia Impex LLC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-15
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Primary Completion: 2024-05
• Study Completion: 2024-05
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DermaShine PRO negative microneedles instrument	35 kDa hyaluronan fragment HA35 injection	-

Primary Outcome Measures

Name	Time	Method
A inflammatory skin thick hardness scale	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.
A skin dryness scale	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	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	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.
An erythema color and area scale	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 Outcome Measures

Name	Time	Method
Self-satisfaction evaluation	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.

Trial Locations

Locations (1)

Nahia Impex LLC; 🇲🇳 Ulaanbaatar, Mongolia