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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment | No Intervention | 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. | |
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EasyDew MD regen cram | Device | No intervention |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihye Lee, Master | CGBio Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Gyeonggi-do | South Korea |
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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 |