Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT01342133
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2011-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sweat Duct Imaging in Mother/Newborn Dyads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053358', 'term': 'Ectodermal Dysplasia 1, Anhidrotic'}], 'ancestors': [{'id': 'D004476', 'term': 'Ectodermal Dysplasia'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2011-04-22', 'studyFirstSubmitQcDate': '2011-04-25', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate the use of a confocal microscope to quantify sweat ducts on the plantar surface of healthy, term newborns', 'timeFrame': 'Day 1', 'description': 'To demonstrate the ease of use of a non-invasive confocal imaging device in the evaluation and measurement of sweat ducts on the plantar surface of healthy, term newborns. These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.'}, {'measure': 'To assess the sweat duct density (i.e. the number of sweat ducts) in a 6 x 6 mm area on the plantar surface of healthy, term newborns, males and females, and the palmar surface of their mothers', 'timeFrame': 'Day 1', 'description': 'These measurements will be used as comparison data in subsequent trials involving those affected by X-Linked Hypohidrotic Ectodermal Dysplasia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['X-Linked Hypohidrotic Ectodermal Dysplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device.', 'detailedDescription': 'In this exploratory study, the investigators propose to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device (Lucid Vivascope®). This approach has the potential to be valuable in repeated sweat endpoint assessments, as the device was selected based on its ease of use, the low risk to patients of all ages, and its ability to generate quantitative data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll up to twenty healthy term newborns and their mothers in the Assessment Nursery at Barnes-Jewish Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy term newborns (37-42 weeks gestation at delivery) in the Assessment Nursery at Barnes-Jewish Hospital, St. Louis, MO\n* Mother of a healthy term newborn who is enrolled in this study\n\nExclusion Criteria:\n\n* Congenital abnormalities affecting skin, nails, or hair in the newborn infant\n* Family history of a sweating disorder'}, 'identificationModule': {'nctId': 'NCT01342133', 'briefTitle': 'Sweat Duct Imaging in Mother/Newborn Dyads', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edimer Pharmaceuticals'}, 'officialTitle': 'Sweat Duct Imaging in Mother/Newborn Dyads', 'orgStudyIdInfo': {'id': 'ECP-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newborns'}, {'label': 'Mothers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Lisa Moscoso, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Dorothy K Grange, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edimer Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}