Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-01 @ 1:13 PM
Study NCT ID:
NCT03989492
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2019-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of the Sympathetic Nervous System in Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2019-06-12', 'studyFirstSubmitQcDate': '2019-06-14', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin blood flow', 'timeFrame': 'Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.', 'description': 'laser Doppler flowmetry'}, {'measure': 'Skin sympathetic nerve activity', 'timeFrame': 'Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.', 'description': 'microneurography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autonomic nervous system', 'skin blood flow', 'skin sympathetic nerve activity'], 'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'Rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. This project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Otherwise healthy males and non-pregnant/non-lactating females with mild to moderate erythematotelangiectactic rosacea, as well as age-sex matched healthy control subjects.\n\nExclusion Criteria:\n\n* Neurological, cardiovascular, respiratory, metabolic, muscular, or other dermatological disorders\n* Current history of alcohol and/or drug abuse\n* Known allergies or hypersensitivities to medications/drugs that are used in the protocol\n* Current smoking or regular smoking within the last 2 years\n* Body mass index \\> 35 kg/m2\n* Medications or supplements which are known to affect neural, cardiovascular, or muscular responses'}, 'identificationModule': {'nctId': 'NCT03989492', 'briefTitle': 'Role of the Sympathetic Nervous System in Rosacea', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Role of the Sympathetic Nervous System in Rosacea', 'orgStudyIdInfo': {'id': '95771'}, 'secondaryIdInfos': [{'id': '1R15AR069912-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R15AR069912-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autonomic responses to stressors', 'description': 'Protocol 1: mental math and handgrip exercise. Protocol 2: systemic stressors and end-organ receptor stimulation. Protocol 3: local heating.', 'interventionNames': ['Other: systemic and local stressors']}], 'interventions': [{'name': 'systemic and local stressors', 'type': 'OTHER', 'description': 'Protocol 1: skin sympathetic nerve activity will be measured during mental math and handgrip exercise. Protocol 2: skin end organ responses will be measured at baseline and in response to systemic stressors and end-organ receptor stimulation. Protocol 3: skin end organ responses will be measured at baseline and during local heating.', 'armGroupLabels': ['Autonomic responses to stressors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40506', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Kristen Metzler-Wilson, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kristen Metzler-Wilson', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kristen Metzler-Wilson', 'investigatorAffiliation': 'University of Kentucky'}}}}