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

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

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

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

Study Overview

• Status: Completed
• Conditions: Skin Lesion
• Intervention / Treatment: Device: EasyDew MD regen cram

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: EasyDew MD regen cram; No intervention; Other Names: No treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eun-ji Kim
• Investigators: Study Director: Jihye Lee, Master, CGBio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: G2205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No