An interventional study of GWAS in Acne Vulgaris, sponsored by Dr.dr.Irma Bernadette, SpKK (K). Recruiting at 1 site in Indonesia. Open to participants aged 17 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by Dr.dr.Irma Bernadette, SpKK (K) · Not applicable, Interventional, and Diagnostic
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.
Research subjects were obtained from the affordable population who met the research criteria and expressed their willingness to participate in the study.
Subject 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.
The 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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 24 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Dr.dr.Irma Bernadette, SpKK (K) is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genetic: GWAS
Genetic: GWAS
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.
Severity of acne vulgaris
Physical examination: identify the number of blackheads, papules, pustules and cysts. Degree 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.
Time frame: 1 year
Population structure
Gene testing of blood sample Genetic Inflation Factor (GIF) \>1.1 or \<1.1 Principal Component Analysis (PCA)
Time frame: 3 months
Genomic Profile
Blood sample examination, processed using GWAS Mutations (SNPs)(1)Present(2)Absent
Time frame: 3 months
Linkage disequilibirium (LD)
Gene testing of blood samples Coefficient 0-1
Time frame: 3 months
Haplotype
Gene testing of blood samples Jumlah gen 1. Satu gen 2. Multipel gen
Time frame: 3 months
SNP Enrichment
Gene testing of blood samples Mutation position
Time frame: 3 months
Association analysis and Association analysis of imputation results
Gene testing of blood samples PCA value
Time frame: 3 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 1 year
Access criteria: data collection
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Dr.dr.Irma Bernadette, SpKK (K)