Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-06 @ 9:04 PM
Study NCT ID:
NCT06501560
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-08-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2024-06-02', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of acne vulgaris', 'timeFrame': '1 year', 'description': 'Physical examination: identify the number of blackheads, papules, pustules and cysts.\n\nDegree of severity:(1)Mild =Comedo\\<20, or inflammatory lesion\\<15, or total lesion\\<30(2)Moderate = Comedo 20-100, or inflammatory lesion15-50, or total lesion 30-125(3)Severe =cyst\\>5, or Comedo\\>100, or inflammatory lesion\\>50, or total lesion\\>125.'}, {'measure': 'Population structure', 'timeFrame': '3 months', 'description': 'Gene testing of blood sample Genetic Inflation Factor (GIF) \\>1.1 or \\<1.1 Principal Component Analysis (PCA)'}, {'measure': 'Genomic Profile', 'timeFrame': '3 months', 'description': 'Blood sample examination, processed using GWAS Mutations (SNPs)(1)Present(2)Absent'}, {'measure': 'Linkage disequilibirium (LD)', 'timeFrame': '3 months', 'description': 'Gene testing of blood samples Coefficient 0-1'}, {'measure': 'Haplotype', 'timeFrame': '3 months', 'description': 'Gene testing of blood samples Jumlah gen\n\n1. Satu gen\n2. Multipel gen'}, {'measure': 'SNP Enrichment', 'timeFrame': '3 months', 'description': 'Gene testing of blood samples Mutation position'}, {'measure': 'Association analysis and Association analysis of imputation results', 'timeFrame': '3 months', 'description': 'Gene testing of blood samples PCA value'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne', 'Acne Vulgaris (AV)', 'Genome Wide Association Study (GWAS)', 'Genetic', 'Genotype', 'Deoxyribonucleic Acid (DNA)', 'Single Nucleotide Polymorphism (SNP)'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This study is a series of descriptive-analytic studies on genomic variants in the facial skin of patients with AV at the Dermatology and Venereology Polyclinic by determining the genetic profile by GWAS examination in AVB and analysing the genetic profile in AVB against differences in geographical location. The research design used was a cross-sectional design.', 'detailedDescription': "Research subjects were obtained from the affordable population who met the research criteria and expressed their willingness to participate in the study.\n\nSubject selection was carried out by purposive sampling method that met the inclusion criteria. The study will be conducted in one visit where the patient and his/her parents come to be given an explanation about the study with a request for informed consent, screening for inclusion and exclusion criteria, anamnesis of facial complaints, taking data on demographics, patient's medical history, patient's medical history, physical examination, taking clinical photos in 5 positions and ending with taking blood samples of the patient and blood samples from both parents of the patient as much as 10 mL.\n\nThe study will be conducted in three places, namely in Jakarta, Padang, and Manado. In sampling in Padang and Manado, to prevent damage to the samples that have been taken, the samples will be stored at a temperature of -20C, then when brought to Jakarta will use a cooler box along with an ice pack at a temperature of 2-3C, before being processed in the Bioinformatics Core Facilities IMERI laboratory, Jakarta. When the samples are collected in Jakarta, the blood samples will be immediately stored in the laboratory at -20C."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females with AVB aged 17-21 years\n* Both parents of complete subjects with or without a history of acne vulgaris aged up to 60 years\n* Patients and parents are willing to participate in the study and sign informed consent.\n\nExclusion Criteria:\n\n* Patients who have other inflammatory or infectious diseases especially on the face\n* Have genetic diseases or disorders\n* Diagnosed with primary or secondary immunodeficiency diseases\n* Using oral or systemic antibiotic, anti-inflammatory, retinoid or hormone therapy in the past month.'}, 'identificationModule': {'nctId': 'NCT06501560', 'briefTitle': 'Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia', 'orgStudyIdInfo': {'id': 'Univ_Indo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'interventionNames': ['Genetic: GWAS']}, {'type': 'EXPERIMENTAL', 'label': 'clinical examination', 'interventionNames': ['Genetic: GWAS']}], 'interventions': [{'name': 'GWAS', 'type': 'GENETIC', 'description': 'In GWAS studies, data are collected to determine common variants in a number of individuals, either with or without a common trait (for example,. disease) across the genome, using genome wide SNP arrays.', 'armGroupLabels': ['Lifestyle counseling', 'clinical examination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'facility': 'Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Irma Bernadette, Professor', 'role': 'CONTACT', 'email': 'Irma_bernadette@yahoo.com', 'phone': '+62818130761'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'The results of this study are expected to be the initial stage for further research on genetic profiles in AVB, Benefits for the Field of Community Service-Improve clinician knowledge about genetic profiles in AVB-The results of this study are expected to be used as a reference in acne vulgaris management services so that they can produce more measurable and effective therapy. and provide a positive impact for RSCM to improve optimal service to Dermatology and Venereology patients.', 'accessCriteria': 'data collection'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr.dr.Irma Bernadette, SpKK (K)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indonesia Medical Education and Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.KK (K)', 'investigatorFullName': 'Dr.dr.Irma Bernadette, SpKK (K)', 'investigatorAffiliation': 'Indonesia University'}}}}