Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT03411733
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2018-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and stool samples were retained for a short period (few hours) till completion of laboratory analyses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2018-01-20', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H.pylori infection', 'timeFrame': 'one year', 'description': 'Prevalence of H.pylori infection among acne group and control group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne vlugaris', 'prevalence', 'Helicobacter Pylori'], 'conditions': ['Helicobacter Pylori Infection', 'Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients.', 'detailedDescription': 'The study included patients with acne vulgaris and healthy control participants. The study recruited both sexes, all grades of acne, adolescents and young adults.\n\nAll patients were subjected to complete history, general and skin examination Acne vlugaris Patients were classified into mild, moderate and severe according to the classification of American Academy of dermatology for acne vulgaris.\n\nDetection of H. pylori infection:\n\nBlood and stool samples were taken from each participant and was directly transferred to laboratory for detection of H. Pylori antigen and antibody.\n\nAn enzyme-linked immune sorbent assay (ELISA) was used for quantitative assessment of IgG antibodies against H.Pylori in human serum.\n\nA monoclonal antibodies based enzyme-linked immunosorbent assay was used to detect H.Pylori specific antigen in stool samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acne vulgaris and presented to Dermatology outpatient clinic, Sohag University hospital.\n\nHealthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acne vulgaris patients\n* Healthy volunteers (control)\n\nExclusion Criteria:\n\n* Patients with a history of drug intake that affects H. Pylori such as proton-pump inhibitors, clarithromycin, tetracyclines, amoxicillin or metronidazole within previous two weeks were excluded.'}, 'identificationModule': {'nctId': 'NCT03411733', 'briefTitle': 'Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Prevalence of Helicobacter Pylori in Patients With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'HPAV001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acne vlugaris group', 'description': 'Included recruited patients with acne vulgaris Intervention: Blood and stool samples collection', 'interventionNames': ['Other: Blood and stool samples collection']}, {'label': 'Control group', 'description': 'Included healthy participants Intervention: Blood and stool samples collection', 'interventionNames': ['Other: Blood and stool samples collection']}], 'interventions': [{'name': 'Blood and stool samples collection', 'type': 'OTHER', 'description': 'Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection', 'armGroupLabels': ['Control group', 'acne vlugaris group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Dermatology outpatient clinic, Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Ramadan Saleh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sohag Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All available data shall be shared with other researchers upon their request after agreement of study director'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician, Department of Dermatology, Sohag Educational Hospital', 'investigatorFullName': 'Dina Ali', 'investigatorAffiliation': 'Sohag University'}}}}