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

Skin Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05994781
• Other study ID #: G2205
• Status: Completed
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: CGBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Skin Lesion

Intervention

Device:
• EasyDew MD regen cram
No intervention

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Eun-ji Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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