Clinical trial NCT06025058: Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Lead sponsor: CGBio Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Transepidermal water loss
timeFrame: before and one month, 3month after medical device application with GP SKin(machine/measuring the degree of moisture skin water loss)
Secondary outcomes:
measure: Itching score
timeFrame: Before, after one month after application, 3 month after application
measure: VSS
timeFrame: Before, after one month after application, 3 month after application
measure: BREAST-Q Survey Assessment
timeFrame: Before, after one month after application, 3 month after application
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: CGBio Inc.
name: Jihye Lee, Master
role: STUDY_DIRECTOR
References: