Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-30 @ 12:39 PM
Study NCT ID:
NCT05982535
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neopep-S Ingredient Easy Dew MD Regen Cream
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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-06', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-08-06', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transepidermal water loss', 'timeFrame': 'before and one month after medical device application', 'description': 'Percutaneous moisture loss measured'}], 'secondaryOutcomes': [{'measure': 'Investigator Global Assessment Scale', 'timeFrame': 'before medical device application and one month after medical device application', 'description': "Assess the patient's overall condition /lowest 0 score ( best score) to highest 30 score( worst score)"}, {'measure': 'Dermatology Life Quality Index', 'timeFrame': 'before medical device application and one month after medical device application', 'description': 'Assess patient quality of life / lowest 0 score ( best score) to highest 4 score( worst score)'}, {'measure': 'Itching score', 'timeFrame': 'before medical device application and one month after medical device application', 'description': 'Evaluate the Itching scale / lowest 1 score ( best score) to highest 5 score( worst score)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Skin']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to provide patients diagnosed with dry skin due to various causes such as atopic dermatitis and Yangjin The effect on skin regeneration after applying EasyDew MD Regen Cream containing Neopep-S, a regeneration factor, and It is intended to assess safety.', 'detailedDescription': "The total study period for this clinical study is 12 months from the date of IRB approval, led by researchers from a single institution It's a clinical study. The individual participation period of the participant is one month.\n\nSubjects are those diagnosed with dry skin due to a variety of factors (and/or courts) Agents) perform screening tests after agreeing in writing to participate in the clinical study.\n\nEvaluating the screening test results, and subjects who meet the selection criteria and do not meet the exclusion criteria, for clinical research It must be registered. Random assignments of the study group and control group are conducted in a random number table at a 5:5 ratio.\n\n* Control group: 10 people with dexian med cream\n* Research Group: 10 people applying EasyDew MD Regen Cream Clinical study subjects are randomly assigned to control and study groups. The control group is Dexian, a foreign medical device product Med cream is applied, and in the case of the study group, EasyDewMD Regen cream provided through prescription is applied. clinical practice Subjects apply an appropriate amount twice a day (morning and evening) to skin areas with dry skin symptoms and can be absorbed well Let's make it happen. After applying the medical device for clinical research, the progress is observed for one month, and the subject is subject to about one month of clinical research During the period, research institutes will be regularly visited to evaluate their validity and safety on the day of screening (Visit1), the day of medical device application (Visit2), 2 weeks after medical device application (Visit3), and 1 month after application (Visit4)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects diagnosed with xerotic skin among adults aged 19 to 80 years\n2. Subjects who have voluntarily decided to participate in this clinical study and signed a written informed consent\n\nExclusion Criteria:\n\n1. Subjects with uncontrolled diabetes\n2. Immunosuppressants, corticosteroids, cytotoxic drugs, anticoagulants, etc. are included in the results You are on long-term or scheduled to receive medication that may affect you a person who is subject to\n3. Acute or chronic skin disease; stage in progress or active in the area of application Subject to bacterial or viral infection\n4. Where the researcher's judgment determines that participation in the study is inappropriate"}, 'identificationModule': {'nctId': 'NCT05982535', 'briefTitle': 'Neopep-S Ingredient Easy Dew MD Regen Cream', 'organization': {'class': 'INDUSTRY', 'fullName': 'CGBio Inc.'}, 'officialTitle': 'The Application of Neopep-S Ingredient Easy Dew MD Regen Cream in the Indication of Dry Skin A Prospective Researcher-led Clinical Study to Assess Efficacy and Safety', 'orgStudyIdInfo': {'id': 'G2206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Easy Dew MD Regen Cream', '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']}, {'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', '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.'}}}}