Clinical trial NCT05994781: A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Lead sponsor: CGBio Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: TEWL score
timeFrame: Before, after one month after application, 3 month after application
Secondary outcomes:
measure: Investigator Global Assessment scale
timeFrame: Before, after one month after application, 3 month after application
measure: Dermatology Life Quality Index
timeFrame: Before, after one month after application, 3 month after application
measure: itching scale
timeFrame: Before, after one month after application, 3 month after application
measure: VSS
timeFrame: Before, after one month after application, 3 month after application
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: CGBio Inc.
name: Jihye Lee, Master
role: STUDY_DIRECTOR
References: