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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: 35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Skin Inflammation

Conditions

Skin Inflammation, Cosmetic Skin

Being tested

35 kDa hyaluronan fragment HA35 injection

Keywords

whitening, pore size, skin dryness, erythema, skin hardness

Medical subject headings

Dermatitis, Erythema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 35 kDa hyaluronan fragment HA35 injectionDrug

  Also called HA35

  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 ).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: 120 minutes and 960 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted26 Apr 2024
2. Study start15 Apr 2024
3. Primary completion12 May 2024
4. Study completion22 Jun 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Skin InflammationStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.