NCT06025058

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

Researcher-led Clinical Study to Evaluate the Effectiveness and Safety of the Application of Neopep-S-based Easy Dew MD Regen Cream in Patients Under Radiotherapy After Breast Tumor Resection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Eun-ji Kim · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Lesion

Interventions

Type	Name	Description
DEVICE	Easy 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.

Timeline

• Start date: 2022-11-11
• Primary completion: 2023-07-27
• Completion: 2023-07-28
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: South Korea