NCT05994781

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eun-ji Kim · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Lesion

Interventions

Type	Name	Description
DEVICE	EasyDew MD regen cram	No intervention

Timeline

• Start date: 2022-11-11
• Primary completion: 2023-06-27
• Completion: 2023-06-30
• First posted: 2023-08-16
• Last updated: 2023-08-22

Locations

1 site across 1 country: South Korea