Ajou University Hospital
Gyeonggi-do, South Korea
NCT Number: NCT06025058
This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Gyeonggi-do, South Korea
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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)
Eun-ji Kim
Industry
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
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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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