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

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

Study Overview

• Status: Completed
• Conditions: Skin Lesion
• Intervention / Treatment: Device: Easy Dew MD Regen Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physiogel Stability Intensive Cream MD; 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.	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.; Other Names: Physiogel Stability Intensive Cream MD
Experimental: Easy Dew MD Regen Cream; 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.	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.; Other Names: Physiogel Stability Intensive Cream MD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss	Percutaneous moisture loss measured	before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VSS	Vancouver Scar Scale/ No range of upper and lower score, the lower is best	Before, after one month after application, 3 month after application
Itching score	Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst	Before, after one month after application, 3 month after application
BREAST-Q Survey Assessment	Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)	Before, after one month after application, 3 month after application

Collaborators and Investigators

• Sponsor: Eun-ji Kim
• Investigators: Study Director: Jihye Lee, Master, CGBio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: G2207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No