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Completed

NCT Number: NCT06025058

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

This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.

Completed

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Physiogel Stability Intensive Cream MD

Primary outcomes

  1. Transepidermal water loss

    Time frame: 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 outcomes

  1. Itching score

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Eun-ji Kim

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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