Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection

Eun-ji Kim

Status: Completed

Conditions: Skin Lesion

Treatments: Device: Easy Dew MD Regen Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT06025058

G2207

Details and patient eligibility

About

This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Easy Dew MD Regen Cream

Experimental group

Description:

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.

Treatment:

Device: Easy Dew MD Regen Cream

Physiogel Stability Intensive Cream MD

Active Comparator group

Description:

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.

Treatment:

Device: Easy Dew MD Regen Cream