Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00764920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2008-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skin Imaging With Technologies in Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collect information on normal and lesional skin', 'timeFrame': 'up to 12 weeks', 'description': 'Develop non-invasive imaging modalities for assessment of skin.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human skin'], 'conditions': ['Pigmented Skin Lesion of Uncertain Nature']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. The researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. Skin conditions to be studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.', 'detailedDescription': 'Normal and lesional skin will be assessed by the following imaging modalities:\n\n1. Laser Speckle Imaging can provide information about relative blood flow in a tissue. In skin it can be used to determine what areas have more blood flow and whether a particular intervention or treatment affects blood flow.\n2. Optical Coherence Tomography and Optical Doppler Tomography can provide pictures of blood vessels in an area of the body and can also tell how fast blood is flowing in that area.\n3. Photon Migration Spectroscopy can provide information about the amount of blood, oxygen, fat and water is in a tissue.\n4. Multi-Spectral Imaging can provide a 3 dimensional image of structures within the skin.\n5. Multiphoton Microscopy can provide images of structures of the skin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from University of California Irvine Medical Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult male or female 7 and older; able to carry out study instructions\n\nExclusion Criteria:\n\n* Younger than 7 years old\n* pregnant woman\n* breast feeding'}, 'identificationModule': {'nctId': 'NCT00764920', 'briefTitle': 'Skin Imaging With Technologies in Development', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Non-invasive Imaging Modalities for Assessment of Normal and Lesional Skin', 'orgStudyIdInfo': {'id': '20086307'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Skin Imaging', 'description': 'non-invasive imaging modalities for assessment of skin', 'interventionNames': ['Device: non-invasive imaging modalities for assessment of skin']}], 'interventions': [{'name': 'non-invasive imaging modalities for assessment of skin', 'type': 'DEVICE', 'description': 'skin imaging', 'armGroupLabels': ['Skin Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Beckman Laser Institute Medical Clinic', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Kristen M Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute University of California Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Departments of Dermatology and Surgery', 'investigatorFullName': 'Kristen Kelly', 'investigatorAffiliation': 'University of California, Irvine'}}}}