Acne VulgarisNCT06501560
Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.
A study testing GWAS in people with Acne Vulgaris, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- GWAS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 17 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: 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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- GWAS
- Keywords
- Acne, Acne Vulgaris (AV), Genome Wide Association Study (GWAS), Genetic, Genotype, Deoxyribonucleic Acid (DNA), Single Nucleotide Polymorphism (SNP)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWASGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Genetic: GWAS |
| clinical examination | Experimental | Not described Receives: Genetic: GWAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Population structure
Gene testing of blood sample Genetic Inflation Factor (GIF) >1.1 or <1.1 Principal Component Analysis (PCA)
Measured: 3 months
Genomic Profile
Blood sample examination, processed using GWAS Mutations (SNPs)(1)Present(2)Absent
Measured: 3 months
Linkage disequilibirium (LD)
Gene testing of blood samples Coefficient 0-1
Measured: 3 months
Haplotype
Gene testing of blood samples Jumlah gen
- Satu gen
- Multipel gen
Measured: 3 months
SNP Enrichment
Gene testing of blood samples Mutation position
Measured: 3 months
Association analysis and Association analysis of imputation results
Gene testing of blood samples PCA value
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Oct 2023
- Primary completion30 Nov 2023
- Study completion17 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia Medical Education and Research Institute
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501560
- Sponsor's protocol ID
- Univ_Indo
- Status last verified
- Jul 2024
- First submitted
- 2 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia
- ClinicalTrials.gov ID
- NCT06501560
- Acronym / sponsor ID
- Univ_Indo
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Acne Vulgaris (AV), Genome Wide Association Study (GWAS), Genetic, Genotype, Deoxyribonucleic Acid (DNA), Single Nucleotide Polymorphism (SNP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Collaborators
- Indonesia Medical Education and Research Institute
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 17 Aug 2024 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Genetic: GWAS |
| clinical examination | Experimental | Genetic: GWAS |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GWASIn 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. | Genetic | Lifestyle counseling, clinical examination |
Primary outcome
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.
Population structure
Time frame: 3 months
Gene testing of blood sample Genetic Inflation Factor (GIF) >1.1 or <1.1 Principal Component Analysis (PCA)
Genomic Profile
Time frame: 3 months
Blood sample examination, processed using GWAS Mutations (SNPs)(1)Present(2)Absent
Linkage disequilibirium (LD)
Time frame: 3 months
Gene testing of blood samples Coefficient 0-1
Haplotype
Time frame: 3 months
Gene testing of blood samples Jumlah gen 1. Satu gen 2. Multipel gen
SNP Enrichment
Time frame: 3 months
Gene testing of blood samples Mutation position
Association analysis and Association analysis of imputation results
Time frame: 3 months
Gene testing of blood samples PCA value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GWAS in people with Acne Vulgaris, run by Dr.dr.Irma Bernadette, SpKK (K) at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irma Bernadette, Professor (+62818130761, Irma_bernadette@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of acne vulgaris (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.