A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream

Study Overview
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Brief Summary
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This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.

Detailed Description
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Subjects need tissue transplantation to repair skin defects, so partial layer skin transplantation is performed. After proceeding, the patient is no longer subject to exudation. Subjects (and/or legal representatives) have agreed in writing to participate in the clinical study Perform a post-screening test. Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria those who do not are registered for clinical research. In the case of the study group among the subjects of the clinical study, whether partial layer skin transplantation was performed or not, Apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well. The control group is a non-treatment group, and for 3 months after the procedure. General moisturizers that have been used or will be used are available. The control group's Moisturizer is recommended twice a day (morning and evening) on whether skin grafts are collected or not Apply and allow good absorption. After applying medical devices and moisturizers for clinical research, the progress will be observed for 3 months, Subjects are a screening visit (Visit1), the day of medical device application (Visit2), and after medical device application. Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and it will be evaluated for safety.

Official Title
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A Prospective Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Partial Layer Skin Transplantation

Conditions
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Skin Lesion

Intervention / Treatment
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* Device: EasyDew MD regen cram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults over the age of 19 Subjects with partial layer skin transplantation There is no evidence of infection in the skin transplant process, and exudate is no longer present a person who does not arise Decide to participate in this clinical study arbitrarily and in the written informed consent a person Exclusion Criteria: showing signs of infection requiring antibiotic administration throughout the body or skin transplantation Case In situations where the requirements of a clinical study cannot be complied with When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No treatment<br>The control group is a non-treatment group, and for 3 months after the procedure, general moisturizers that have been used or will be used are available. | |
| Experimental: Treatment<br>In the case of the study group among the subjects of the clinical study, The experimental group apply an appropriate amount of EasyDew MD Regen Cream twice a day (morning and evening) and can be absorbed well. | Device: EasyDew MD regen cram<br>* No intervention<br>* Other names: No treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEWL score | Transepidermal water loss score/ No range of upper and lower score, the lower is best | Before, after one month after application, 3 month after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment scale | Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score) | Before, after one month after application, 3 month after application | 
| Dermatology Life Quality Index | Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score) | Before, after one month after application, 3 month after application | 
| itching scale | Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score) | Before, after one month after application, 3 month after application | 
| VSS | Vancouver Scar Scale/ No range of upper and lower score, the lower is best | Before, after one month after application, 3 month after application |