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

NCT ID: NCT06025058

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2023-07-28

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.

Conditions

Skin Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Easy Dew MD Regen Cream

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Easy Dew MD Regen Cream

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Physiogel Stability Intensive Cream MD

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eun-ji Kim

INDUSTRY

Sponsor Role: lead

Responsible Party

Eun-ji Kim

Clinical Trial Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jihye Lee, Master

Role: STUDY_DIRECTOR

CGBio Inc.

Locations

Ajou University Hospital

Gyeonggi-do, , South Korea

Countries

South Korea

Other Identifiers

G2207

Identifier Type: -

Identifier Source: org_study_id