Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-28 @ 5:31 PM
Study NCT ID:
NCT01892150
Status:
COMPLETED
Last Update Posted:
2014-03-31
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histologic Response to UVA and UVB Exposure During the Use of Sunscreen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013473', 'term': 'Sunscreening Agents'}], 'ancestors': [{'id': 'D011837', 'term': 'Radiation-Protective Agents'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003879', 'term': 'Dermatologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-27', 'studyFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2013-06-30', 'lastUpdatePostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '8-OH-dG Staining', 'timeFrame': '2 Months', 'description': 'Review difference in 8-OH-dG staining in tissue biopsy before and after UVA / UVB irradiation to evaluate the quantity of free radical species after UV exposure'}, {'measure': 'MMP1 Staining', 'timeFrame': '2 Months', 'description': 'Review difference in MMP1 staining in tissue biopsy before and after UVA / UVB irradiation to evaluate the collagen and ground substances destruction after UV exposure'}], 'primaryOutcomes': [{'measure': 'H&E Staining', 'timeFrame': '2 Months', 'description': 'Review difference in H\\&E staining in tissue biopsy before and after UVA / UVB irradiation'}], 'secondaryOutcomes': [{'measure': 'Tyrosinase Staining', 'timeFrame': '2 Months', 'description': 'Review difference in Tyrosinase staining in tissue biopsy before and after UVA / UVB irradiation to evaluate the effects of pigment darkening after UV exposure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Solar Elastosis']}, 'referencesModule': {'references': [{'pmid': '7822517', 'type': 'RESULT', 'citation': 'Lavker RM, Gerberick GF, Veres D, Irwin CJ, Kaidbey KH. Cumulative effects from repeated exposures to suberythemal doses of UVB and UVA in human skin. J Am Acad Dermatol. 1995 Jan;32(1):53-62. doi: 10.1016/0190-9622(95)90184-1.'}]}, 'descriptionModule': {'briefSummary': 'Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.', 'detailedDescription': 'Premature aging can be prevented by using sunscreen. Currently, anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects aged 35-65 years who were scheduled for abdominoplasty\n* the excised area should be larger than 18x10 cm2\n* no skin diseases or lesions on the excised area\n* no topical treatment on excised area more than 1 month prior to this study\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* have tattoo or striae distensae on abdomen'}, 'identificationModule': {'nctId': 'NCT01892150', 'briefTitle': 'Histologic Response to UVA and UVB Exposure During the Use of Sunscreen', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Histologic Response to UVA and UVB Exposure During the Use of Sunscreen With Anti-inflammatory and Anti-oxidant Properties - A Pilot Study', 'orgStudyIdInfo': {'id': 'Siriraj-Eucerin02'}, 'secondaryIdInfos': [{'id': '721/2555(EC2)', 'type': 'OTHER', 'domain': 'Siriraj Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sunscreen', 'description': 'Apply sunscreen before and after UVA and UVB irradiation', 'interventionNames': ['Other: Sunscreen']}], 'interventions': [{'name': 'Sunscreen', 'type': 'OTHER', 'description': 'Apply sunscreen before and after UVA and UVB irradiation', 'armGroupLabels': ['Sunscreen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Rungsima Wanitphakdeedecha, MD, MA, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}