Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-28 @ 9:05 PM
Study NCT ID:
NCT06025058
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2023-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection
Sponsor:
Eun-ji Kim
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: