Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-18 @ 1:39 AM
Study NCT ID:
NCT03009903
Status:
UNKNOWN
Last Update Posted:
2017-01-04
First Post:
2016-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-30', 'studyFirstSubmitDate': '2016-12-30', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection and analysis of facial P. acnes presence', 'timeFrame': 'Day 0 and week 8 (optional)'}], 'secondaryOutcomes': [{'measure': 'Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.', 'timeFrame': 'Day 0 and week 8 (optional'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects.', 'detailedDescription': 'This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. An additional P. acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI decision to explore whether there is a correlation between P. acnes bacterial presence and fluorescent signal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults between 14 to 50 years of age inclusive at the time of signing the informed consent\n2. Able to provide written informed consent\n3. Subjects who are willing to undergo pore strip treatment using the cosmetically acceptable pore strip product\n4. Subjects who are willing to provide comprehensive demographic data using questionnaires\n\nExclusion Criteria:\n\n1. Unwilling or unable to follow the procedures outlined in the protocol\n2. Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1\n3. Subjects treated with immunosuppressant agents\n4. Pregnant subjects'}, 'identificationModule': {'nctId': 'NCT03009903', 'briefTitle': 'Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage', 'organization': {'class': 'INDUSTRY', 'fullName': 'MBcure Ltd'}, 'officialTitle': 'Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans', 'orgStudyIdInfo': {'id': 'MBC-CL-01-2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'P. acne subjects', 'description': '14-50 year of age, P. acne diagnosed subjects'}, {'label': 'None P. acne subjects', 'description': '14-50 year of age, none P. acne diagnosed subjects'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jonathan Shapiro, MD', 'role': 'CONTACT', 'email': 'jonmidi@gmail.com', 'phone': '972.50.5759516'}], 'overallOfficials': [{'name': 'Jonathan Shapiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maccabi Healthcare Services, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '2 sites to be activated. Dr. Shapiro is considered as PI in both sites'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MBcure Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}