Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-28 @ 2:52 AM
Study NCT ID:
NCT01305057
Status:
COMPLETED
Last Update Posted:
2011-02-28
First Post:
2011-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Test on Skin Hydration and Skin Barrier Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-25', 'studyFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL)', 'timeFrame': 'Before application, 1 week, 2 week and 4 weeks after application', 'description': 'Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation (without P-IP, oil-in-water emulsion type) on the other side twice daily (morning and evening) for 28 days. Skin surface water contents and TEWLs were measured at the time frame described above and the results were analyzed as a change from a value of before-application at each measurement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dry skin condition'], 'conditions': ['Dry Skin']}, 'descriptionModule': {'briefSummary': 'The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.', 'detailedDescription': 'It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '33 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy skin\n\nExclusion Criteria:\n\n* don't use any moisturizer"}, 'identificationModule': {'nctId': 'NCT01305057', 'briefTitle': 'Efficacy Test on Skin Hydration and Skin Barrier Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cosmos Technical Center'}, 'officialTitle': 'Human Use Test on Skin Hydration and Skin Barrier Function', 'orgStudyIdInfo': {'id': 'Cosmos1'}, 'secondaryIdInfos': [{'id': 'hydration-1', 'type': 'OTHER', 'domain': 'Cosmos Technical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation of P-IP on hydration and barrier function', 'description': 'Effects of P-IP on improvement of skin hydration and TEWL were examined.', 'interventionNames': ['Other: Pyridoxine tri-isopalmitate']}], 'interventions': [{'name': 'Pyridoxine tri-isopalmitate', 'type': 'OTHER', 'description': '2% dosage, oil-in-water emulsion, twice a day, 28 days', 'armGroupLabels': ['Evaluation of P-IP on hydration and barrier function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '174-0046', 'city': 'Itabashi-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Cosmos Technical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cosmos Technical Center', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Dundee', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Hitoshi Masaki', 'oldOrganization': 'Cosmos Technical Center'}}}}