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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Easy Dew MD Regen Cream | Experimental | 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. |
|
| Physiogel Stability Intensive Cream MD | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Easy Dew MD Regen Cream | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal water loss | Percutaneous moisture loss measured | before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss) |
| Measure | Description | Time Frame |
|---|---|---|
| Itching score | Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihye Lee, Master | CGBio Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Gyeonggi-do | South Korea |
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| 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) | Before, after one month after application, 3 month after application |