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临床试验/NCT06501560
NCT06501560招募中不适用

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia

Dr.dr.Irma Bernadette, SpKK (K)2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
2
主要终点
Population structure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
17 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females with AVB aged 17-21 years
  • Both parents of complete subjects with or without a history of acne vulgaris aged up to 60 years
  • Patients and parents are willing to participate in the study and sign informed consent.

排除标准

  • Patients who have other inflammatory or infectious diseases especially on the face
  • Have genetic diseases or disorders
  • Diagnosed with primary or secondary immunodeficiency diseases
  • Using oral or systemic antibiotic, anti-inflammatory, retinoid or hormone therapy in the past month.

结局指标

主要结局

Population structure

时间窗: 3 months

Gene testing of blood sample Genetic Inflation Factor (GIF) \>1.1 or \<1.1 Principal Component Analysis (PCA)

Severity of acne vulgaris

时间窗: 1 year

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.

Genomic Profile

时间窗: 3 months

Blood sample examination, processed using GWAS Mutations (SNPs)(1)Present(2)Absent

SNP Enrichment

时间窗: 3 months

Gene testing of blood samples Mutation position

Association analysis and Association analysis of imputation results

时间窗: 3 months

Gene testing of blood samples PCA value

Linkage disequilibirium (LD)

时间窗: 3 months

Gene testing of blood samples Coefficient 0-1

Haplotype

时间窗: 3 months

Gene testing of blood samples Jumlah gen 1. Satu gen 2. Multipel gen

次要结局

未报告次要终点

研究者

发起方
Dr.dr.Irma Bernadette, SpKK (K)
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr.dr.Irma Bernadette, SpKK (K)

Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.KK (K)

Indonesia University

研究点 (2)

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