This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
The subject applies the provided medical device twice a day (morning and evening) to areas with symptoms of dry skin so that it can be absorbed well.
Ajou University Hospital
Gyeonggi-do, South Korea
Transepidermal water loss
Percutaneous moisture loss measured
Time frame: before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)
Itching score
Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst
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
BREAST-Q Survey Assessment
Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)
Time frame: Before, after one month after application, 3 month after application
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