Clinical trial NCT06501560: Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.
Official title: Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne
Acne Vulgaris (AV)
Genome Wide Association Study (GWAS)
Genetic
Genotype
Deoxyribonucleic Acid (DNA)
Single Nucleotide Polymorphism (SNP)
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Indonesia Medical Education and Research Institute
First posted: 2024-07-15
Enrollment: 24
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of acne vulgaris
timeFrame: 1 year
measure: Population structure
timeFrame: 3 months
measure: Genomic Profile
timeFrame: 3 months
measure: Linkage disequilibirium (LD)
timeFrame: 3 months
measure: Haplotype
timeFrame: 3 months
measure: SNP Enrichment
timeFrame: 3 months
measure: Association analysis and Association analysis of imputation results
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: Jakarta
Study officials:
References: