A Prospective Researcher-led Clinical Study of Neopep-S-based EasyDew MD Regen Cream
- Conditions
- Skin Lesion
- Interventions
- Device: EasyDew MD regen cram
- Registration Number
- NCT05994781
- Lead Sponsor
- Eun-ji Kim
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment EasyDew MD regen cram 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.
- Primary Outcome Measures
Name Time Method TEWL score Before, after one month after application, 3 month after application Transepidermal water loss score/ No range of upper and lower score, the lower is best
- Secondary Outcome Measures
Name Time Method Investigator Global Assessment scale Before, after one month after application, 3 month after application Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)
itching scale Before, after one month after application, 3 month after application Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)
Dermatology Life Quality Index Before, after one month after application, 3 month after application Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)
VSS Before, after one month after application, 3 month after application Vancouver Scar Scale/ No range of upper and lower score, the lower is best
Trial Locations
- Locations (1)
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of