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

Eun-ji Kim

Status: Completed

Conditions: Skin Lesion

Treatments: Device: EasyDew MD regen cram

Study type: Interventional

Funder types: Industry

Identifiers

NCT05994781

G2205

Details and patient eligibility

About

This clinical study is conducted prospectively for 3 months after medical device treatment.

It is a comparative clinical study of the leading control group.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

No treatment

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: EasyDew MD regen cram