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NCT Number: NCT06501560

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

17 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

GWAS

Genetic

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.

Primary outcomes

  1. Severity of acne vulgaris

    Time frame: 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.

  2. Population structure

    Time frame: 3 months

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

  3. Genomic Profile

    Time frame: 3 months

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

  4. Linkage disequilibirium (LD)

    Time frame: 3 months

    Gene testing of blood samples Coefficient 0-1

  5. Haplotype

    Time frame: 3 months

    Gene testing of blood samples Jumlah gen

    • Satu gen
    • Multipel gen

  6. SNP Enrichment

    Time frame: 3 months

    Gene testing of blood samples Mutation position

  7. Association analysis and Association analysis of imputation results

    Time frame: 3 months

    Gene testing of blood samples PCA value

Study contacts

Contact information is provided by the study sponsor or research team.

Irma Bernadette, Professor

CONTACT

[email protected]

+62818130761

Sponsors and collaborators

Lead sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Other

Collaborators

  • Indonesia Medical Education and Research Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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