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

NCT06501560 | Recruiting

• 1 other identifier: Univ_Indo
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Keywords

Acne; Acne Vulgaris (AV); Genome Wide Association Study (GWAS); Genetic; Genotype; Deoxyribonucleic Acid (DNA); Single Nucleotide Polymorphism (SNP)

Outcome Measures

Primary Outcomes (7)

• 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.

  1 year

• Population structure

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

  3 months

• Genomic Profile

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

  3 months

• Linkage disequilibirium (LD)

  Gene testing of blood samples Coefficient 0-1

  3 months

• Haplotype

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

  3 months

• SNP Enrichment

  Gene testing of blood samples Mutation position

  3 months

• Association analysis and Association analysis of imputation results

  Gene testing of blood samples PCA value

  3 months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Genetic: GWAS

clinical examination

EXPERIMENTAL

Genetic: GWAS

Interventions

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.

Lifestyle counseling; clinical examination

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr.dr.Irma Bernadette, SpKK (K): lead
• Indonesia Medical Education and Research Institute: collaborator

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Irma Bernadette, Professor

CONTACT

+62818130761; Irma_bernadette@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.KK (K)

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: July 15, 2024
• Study Start: October 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: August 17, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year
• Access Criteria: data collection

Locations

ID (1)