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

NCT06025058 | Completed

• 1 other identifier: G2207
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Itching score

  Before, after one month after application, 3 month after application

• VSS

  Before, after one month after application, 3 month after application

• BREAST-Q Survey Assessment

  Before, after one month after application, 3 month after application

Study Arms (2)

Easy Dew MD Regen Cream

EXPERIMENTAL

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

Physiogel Stability Intensive Cream MD

ACTIVE COMPARATOR

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

Interventions

Easy Dew MD Regen Cream 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.

Also known as: Physiogel Stability Intensive Cream MD

Easy Dew MD Regen Cream; Physiogel Stability Intensive Cream MD

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eun-ji Kim: lead

Study Sites (1)

Ajou University Hospital

Gyeonggi-do, South Korea

Location

Study Officials

• Jihye Lee, Master

  CGBio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trial Manager

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 6, 2023
• Study Start: November 11, 2022
• Primary Completion: July 27, 2023
• Study Completion: July 28, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)