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

NCT ID: NCT05994781

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2023-06-30

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.

Conditions

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Skin Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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No treatment

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

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.

Group Type EXPERIMENTAL

EasyDew MD regen cram

Intervention Type DEVICE

No intervention

Interventions

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EasyDew MD regen cram

No intervention

Intervention Type DEVICE

Other Intervention Names

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No treatment

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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eun-ji Kim

INDUSTRY

Sponsor Role lead

Responsible Party

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Eun-ji Kim

Clinical Trial Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jihye Lee, Master

Role: STUDY_DIRECTOR

CGBio Inc.

Locations

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Ajou University Hospital

Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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G2205

Identifier Type: -

Identifier Source: org_study_id

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