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

• Sponsor: Eun-ji Kim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06025058
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Lesion	Device: Easy Dew MD Regen Cream	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Nov 11, 2022
• Actual Primary Completion Date: Jul 27, 2023
• Actual Study Completion Date: Jul 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

1. Transepidermal water loss [before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)]

   Percutaneous moisture loss measured

Secondary Outcome Measures

1. Itching score [Before, after one month after application, 3 month after application]

   Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst

2. VSS [Before, after one month after application, 3 month after application]

   Vancouver Scar Scale/ No range of upper and lower score, the lower is best

3. BREAST-Q Survey Assessment [Before, after one month after application, 3 month after application]

   Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Gyeonggi-do		Korea, Republic of

Sponsors and Collaborators

• Eun-ji Kim

Investigators

• Study Director: Jihye Lee, Master, CGBio Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eun-ji Kim, Clinical Trial Manager, CGBio Inc.
• ClinicalTrials.gov Identifier: NCT06025058
• Other Study ID Numbers: G2207
• First Posted: Sep 6, 2023
• Last Update Posted: Sep 6, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 6, 2023