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

Skin Lesion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06025058
• Other study ID #: G2207
• Status: Completed
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: July 28, 2023

Study information

• Verified date: September 2023
• Source: CGBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 28, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• Skin Lesion

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Eun-ji Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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