Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02938650
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrosomonas Eutropha on Nitrolipids in the Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '15 healthy controls will participate in the study Another set of healthy controls (n=20) will be recruited so that they participate in blood draws.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alteration in microbiome diversity and species', 'timeFrame': 'one week', 'description': 'We will assess the alteration in the skin microbiome over a one week period by assessing the Shannon Diversity Index'}, {'measure': 'Alteration in nitrolipids in the skin', 'timeFrame': 'one week', 'description': 'we will assess the change in nitrolipid profile of sebum collections from the skin after application of the nitrosomonas spray.'}], 'secondaryOutcomes': [{'measure': 'Alteration in skin cytokines', 'timeFrame': 'one week', 'description': 'we will assess the change in skin cytokines with the use of a non-invasive skin collection.'}, {'measure': 'Alteration in blood lipids', 'timeFrame': 'one week', 'description': 'we will assess the change in blood lipids by performing a blood draw'}, {'measure': 'Blood pressure readings', 'timeFrame': 'one week', 'description': 'blood pressure readings will be performed throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nitrolipid', 'microbiome', 'inflammation', 'cytokine'], 'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and inflammatory cytokines on the skin.', 'detailedDescription': 'We are looking to see how the nitrosomonas alters nitrolipids in the skin and the inflammatory cytokines of the skin.\n\nWe will be using healthy subjects over the course of 2 weeks.\n\nSubjects will be using a neutral cleanser for one week prior to the study, skin microbiome,facial photography, lipid and cytokine measurements will be taken at baseline. Subjects will then start using nitrosomonas spray twice daily for one week.\n\nThere is a portion of the study where the subjects will have skin microbiome, facial photography, lipid measurements, blood pressure measurements and a bloow draw before and after using the nitrosomonas spray for one week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those aged 18 and over\n* Healthy Subjects with clear skin\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners\n* Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome\n* Those who have started new oral medication in the last four weeks\n* Those who have used systemic antibiotics in the last month\n* Those who have used isotretinoin in the last 6 weeks\n* Those who have used topical antibiotics or retinoid in the last two weeks.\n* Those who have autoimmune or metabolic diseases\n* Those who have changed brands of oral contraceptive within the last four weeks\n* Those who have chronic medical disorders\n* Those whose with active skin infections\n* Concomitant use of nitrates\n* Concomitant use of anti-hypertensive agents\n* Those with syncopal episodes'}, 'identificationModule': {'nctId': 'NCT02938650', 'briefTitle': 'Nitrosomonas Eutropha on Nitrolipids in the Skin', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin', 'orgStudyIdInfo': {'id': '916019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nitrosomonas eutropha spray', 'description': 'Subjects will receive nitrosmonas eutropha spray that they will apply twice a day.', 'interventionNames': ['Drug: Nitrosomonas eutropha']}], 'interventions': [{'name': 'Nitrosomonas eutropha', 'type': 'DRUG', 'description': 'Subjects will get nitrosomonas eutropha to apply for one week. There is only one arm to this study. Subjects will apply the medication twice a day for one week.', 'armGroupLabels': ['Nitrosomonas eutropha spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Dermatology Clinical Trials Unit', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Raja K Sivamani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}