Cosmetic Skin, Skin Inflammation
Conditions
Keywords
whitening, pore size, skin dryness, erythema, skin hardness
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.
Interventions
DRUG35 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 ).
Sponsors
Nakhia Impex LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mongolia
Contacts
Primary ContactMizhou Hui
Outcome results
None listed