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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.


Clinical Trial Description

Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at the lesion. 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. - Control group: Physiogel Skin Stability Intensive Cream MD (10 people) - Study Group: EasyDew MD Regen Cream (20 people) The subjects of the clinical study are randomly assigned in a 2:1 ratio between the study group and the control group. In this case, apply the control medical device twice a day (morning and evening) to the radiation treatment area. Apply it. In the case of the research group, easy dew MD Regen Cream was applied to the radiotherapy site. Apply an appropriate amount twice a day (in the evening) to ensure good absorption. The progress for three months after the application of medical devices for clinical research will be observed, and the subjects will be screening visit (Visit1), medical device application day (Visit2), medical device application, and medical device application. Visit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and to be evaluated for safety. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06025058
Study type Interventional
Source CGBio Inc.
Contact
Status Completed
Phase N/A
Start date November 11, 2022
Completion date July 28, 2023

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