Skin Lesion
Conditions
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
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.
Interventions
DEVICEEasy Dew MD Regen Cream
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.
Sponsors
Eun-ji Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults over the age of 19 * The tumor in the breast area is resected and radiotherapy is planned, performed, or Subjects with a history of irradiation * Decide to participate in this clinical study arbitrarily and in the written informed consent a person to whom
Exclusion criteria
* When participating in a clinical study, the findings of radiation dermatitis in the area are shown * A person who shows signs of acute or chronic dermatological diseases * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal water loss | before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss) | Percutaneous moisture loss measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Itching score | Before, after one month after application, 3 month after application | Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst |
| 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 |
| BREAST-Q Survey Assessment | Before, after one month after application, 3 month after application | Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score) |
Countries
South Korea
Outcome results
None listed