An interventional study of EasyDew MD regen cram in Skin Lesion, sponsored by Eun-ji Kim. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Eun-ji Kim · Not applicable, Interventional, and Supportive care
This clinical study is conducted prospectively for 3 months after medical device treatment.
It is a comparative clinical study of the leading control group.
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.
Eun-ji Kim is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
Also known as: No treatment
TEWL score
Transepidermal water loss score/ No range of upper and lower score, the lower is best
Time frame: Before, after one month after application, 3 month after application
Investigator Global Assessment scale
Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Before, after one month after application, 3 month after application
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Eun-ji Kim