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

Primary Purpose

Skin Lesion

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Easy Dew MD Regen Cream
Sponsored by
Eun-ji Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Lesion

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Easy Dew MD Regen Cream

Physiogel Stability Intensive Cream MD

Arm 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.

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.

Outcomes

Primary Outcome Measures

Transepidermal water loss
Percutaneous moisture loss measured

Secondary Outcome Measures

Itching score
Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst
VSS
Vancouver Scar Scale/ No range of upper and lower score, the lower is best
BREAST-Q Survey Assessment
Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)

Full Information

First Posted
August 25, 2023
Last Updated
September 1, 2023
Sponsor
Eun-ji Kim
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1. Study Identification

Unique Protocol Identification Number
NCT06025058
Brief Title
Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eun-ji Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Lesion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Easy Dew MD Regen Cream
Arm Type
Experimental
Arm 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.
Arm Title
Physiogel Stability Intensive Cream MD
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Easy Dew MD Regen Cream
Other Intervention Name(s)
Physiogel Stability Intensive Cream MD
Intervention 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.
Primary Outcome Measure Information:
Title
Transepidermal water loss
Description
Percutaneous moisture loss measured
Time Frame
before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)
Secondary Outcome Measure Information:
Title
Itching score
Description
Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst
Time Frame
Before, after one month after application, 3 month after application
Title
VSS
Description
Vancouver Scar Scale/ No range of upper and lower score, the lower is best
Time Frame
Before, after one month after application, 3 month after application
Title
BREAST-Q Survey Assessment
Description
Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)
Time Frame
Before, after one month after application, 3 month after application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihye Lee, Master
Organizational Affiliation
CGBio Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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