Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT06025058
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2023-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'Percutaneous moisture loss measured'}], 'secondaryOutcomes': [{'measure': 'Itching score', 'timeFrame': 'Before, after one month after application, 3 month after application', 'description': 'Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst'}, {'measure': 'VSS', 'timeFrame': 'Before, after one month after application, 3 month after application', 'description': 'Vancouver Scar Scale/ No range of upper and lower score, the lower is best'}, {'measure': 'BREAST-Q Survey Assessment', 'timeFrame': 'Before, after one month after application, 3 month after application', 'description': 'Evaluate the BREAST-Q Survey Assessment/ lowest 1 score (worst) to highest 10 score( best score)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Lesion']}, 'descriptionModule': {'briefSummary': 'This clinical study is conducted prospectively for 3 months after medical device treatment. It is a comparative clinical study of the leading control group.', 'detailedDescription': 'Subject is a patient who has a tumor removed from the breast and is receiving radiotherapy at the lesion.\n\nSubjects (and/or legal representatives) have agreed in writing to participate in the clinical study.\n\nPerform a post-screening test. Evaluating the screening test results, meeting the selection criteria, and meeting the exclusion criteria.\n\nThose who do not are registered for clinical research.\n\n* Control group: Physiogel Skin Stability Intensive Cream MD (10 people)\n* 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.\n\nIn this case, apply the control medical device twice a day (morning and evening) to the radiation treatment area.\n\nApply it. In the case of the research group, easy dew MD Regen Cream was applied to the radiotherapy site.\n\nApply an appropriate amount twice a day (in the evening) to ensure good absorption.\n\nThe 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.\n\nVisit the research institution regularly for one month (Visit3) and three months after application (Visit4) for validity and to be evaluated for safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adults over the age of 19\n* The tumor in the breast area is resected and radiotherapy is planned, performed, or Subjects with a history of irradiation\n* Decide to participate in this clinical study arbitrarily and in the written informed consent a person to whom\n\nExclusion Criteria:\n\n* When participating in a clinical study, the findings of radiation dermatitis in the area are shown\n* A person who shows signs of acute or chronic dermatological diseases\n* In situations where the requirements of a clinical study cannot be complied with\n* When the researcher's judgment determines that the participation of the study is inappropriate (e.g. Kelloid personality)"}, 'identificationModule': {'nctId': 'NCT06025058', 'briefTitle': 'Neopep-S-based EasyDew MD Regen Cream for Radiotherapy Subject After Breast Tumor Resection', 'organization': {'class': 'INDUSTRY', 'fullName': 'CGBio Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'G2207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Easy Dew MD Regen Cream', 'description': '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.', 'interventionNames': ['Device: Easy Dew MD Regen Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiogel Stability Intensive Cream MD', 'description': '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.', 'interventionNames': ['Device: Easy Dew MD Regen Cream']}], 'interventions': [{'name': 'Easy Dew MD Regen Cream', 'type': 'DEVICE', 'otherNames': ['Physiogel Stability Intensive Cream MD'], 'description': '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.', 'armGroupLabels': ['Easy Dew MD Regen Cream', 'Physiogel Stability Intensive Cream MD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'overallOfficials': [{'name': 'Jihye Lee, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CGBio Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eun-ji Kim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Trial Manager', 'investigatorFullName': 'Eun-ji Kim', 'investigatorAffiliation': 'CGBio Inc.'}}}}