Acne VulgarisNCT05838534
Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients
An observational study of Acne Vulgaris, run by Dr.dr.Irma Bernadette, SpKK (K) at 2 sites in Indonesia.
Trial summary
The aim of this study is to compare the profile of the microbiome on normal skin and acne vulgaris patients. A cross sectional study with 144 samples, male or female between 18-40 years old, from January to May 2023. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- How many people
- 144 participants
- Where
- 2 sitesIndonesia
- Study dates
- 17 Jan 2023to 24 May 2023
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male or female, 18-40 years old, normal skin, diagnosed with mild to severe acne
Who may be able to join
- Male or female, 18-40 years old
- Normal individuals who have not had acne vulgaris in the last 5 years and have never had moderate or severe acne vulgaris
- Patients with mild, moderate, or severe acne vulgaris who have acne vulgaris lesions that are representative of the grade and equally distributed in all facial regions (forehead, cheeks, and chin)
- Patients agree to participate in the study and sign informed consent
Who cannot join
- Pregnancy
- Diagnosed with other inflammatory or infectious diseases on the face
- Diagnosed with psoriasis or have atopic
- Diagnosed with primary or secondary immunodeficiency disease
- Patients with a history of laser therapy or facial dermabrasion within the past month
- Using oral or systemic antibiotics, anti-inflammatory, retinoids or hormone therapy in the last 1 month
- Using topical retinoid therapy, antibiotics, benzoyl peroxide, or other topical products in the last 2 weeks
- Acne conglobata
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
The aim of this study is to compare the profile of the microbiome on normal skin and acne vulgaris patients. A cross sectional study with 144 samples, male or female between 18-40 years old, from January to May 2023.
Read the detailed description
Recently, research on the role of the microbiome in the process of acne vulgaris has continued to grow. Seeing the important role of the microbiome in maintaining the balance of skin health, this study aims to compare the profile of the microbiome on normal skin and on acne vulgaris patients, in order to gain a deeper understanding the role of the microbiome in acne vulgaris and also to compare skin microbiome features in various degrees of acne vulgaris severity. This research is an observational study with a cross sectional design. Subject selected by consecutive sampling, with total 144 samples consists of males and females age 18-40.
There will be two visits in this research. The first visit, for screening patients with requests for informed consent, giving facial soap, screening for inclusion and exclusion criteria, screening for facial skin complaints and facial care habits, collecting data on patient demographics and medical history, physical examination, sebumeter examination to measure sebum levels on facial skin, and taking clinical photos for documentation. The second visit is collecting microbiome data which will be taking in 1 to 2 weeks after the first visit. Using swab method to take microbiome samples, after that, there will be DNA extraction, amplification and sequencing were carried out on the sample and the Shannon Index will be calculated. Then, the data will be tabulated and analyzed according to the hypothesis.
- Conditions
- Acne Vulgaris
- Keywords
- Skin Microbiome, Normal Skin, Acne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Skin | Not described | |
| Mild Acne Vulgaris | Not described | |
| Moderate Acne Vulgaris | Not described | |
| Severe Acne Vulgaris | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of skin microbiome features on normal and acne vulgaris skin
Using the swab method on facial skin for microbiome sampling, DNA extraction, amplification, and sequencing were carried out on the sample and the Shannon Index will be calculated. Then, the data will be tabulated and analyzed.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start17 Jan 2023
- Primary completion24 Mar 2023
- Study completion24 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma Bernadette Sitohang, MD, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838534
- Sponsor's protocol ID
- SkinMicrobiomeComparison
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manurung THP, Sitohang IBS, Agustin T. Staphylococcus caprae and Staphylococcus epidermidis define the skin microbiome among different grades of acne vulgaris. Arch Dermatol Res. 2024 Dec 30;317(1):156. doi: 10.1007/s00403-024-03581-1.
PubMed 39738874
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients
- ClinicalTrials.gov ID
- NCT05838534
- Acronym / sponsor ID
- SkinMicrobiomeComparison
- Conditions
- Acne Vulgaris
- Keywords
- Skin Microbiome, Normal Skin, Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 May 2023 (estimated)
- First posted
- 1 May 2023 (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.
The aim of this study is to compare the profile of the microbiome on normal skin and acne vulgaris patients. A cross sectional study with 144 samples, male or female between 18-40 years old, from January to May 2023.
Detailed description
Recently, research on the role of the microbiome in the process of acne vulgaris has continued to grow. Seeing the important role of the microbiome in maintaining the balance of skin health, this study aims to compare the profile of the microbiome on normal skin and on acne vulgaris patients, in order to gain a deeper understanding the role of the microbiome in acne vulgaris and also to compare skin microbiome features in various degrees of acne vulgaris severity. This research is an observational study with a cross sectional design. Subject selected by consecutive sampling, with total 144 samples consists of males and females age 18-40.
There will be two visits in this research. The first visit, for screening patients with requests for informed consent, giving facial soap, screening for inclusion and exclusion criteria, screening for facial skin complaints and facial care habits, collecting data on patient demographics and medical history, physical examination, sebumeter examination to measure sebum levels on facial skin, and taking clinical photos for documentation. The second visit is collecting microbiome data which will be taking in 1 to 2 weeks after the first visit. Using swab method to take microbiome samples, after that, there will be DNA extraction, amplification and sequencing were carried out on the sample and the Shannon Index will be calculated. Then, the data will be tabulated and analyzed according to the hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Skin | – | – |
| Mild Acne Vulgaris | – | – |
| Moderate Acne Vulgaris | – | – |
| Severe Acne Vulgaris | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male or female, 18-40 years old, normal skin, diagnosed with mild to severe acne
Key inclusion criteria (4 listed)
- Male or female, 18-40 years old
- Normal individuals who have not had acne vulgaris in the last 5 years and have never had moderate or severe acne vulgaris
- Patients with mild, moderate, or severe acne vulgaris who have acne vulgaris lesions that are representative of the grade and equally distributed in all facial regions (forehead, cheeks, and chin)
- Patients agree to participate in the study and sign informed consent
Key exclusion criteria (8 listed)
- Pregnancy
- Diagnosed with other inflammatory or infectious diseases on the face
- Diagnosed with psoriasis or have atopic
- Diagnosed with primary or secondary immunodeficiency disease
- Patients with a history of laser therapy or facial dermabrasion within 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.
Primary outcome
Comparison of skin microbiome features on normal and acne vulgaris skin
Time frame: up to 16 weeks
Using the swab method on facial skin for microbiome sampling, DNA extraction, amplification, and sequencing were carried out on the sample and the Shannon Index will be calculated. Then, the data will be tabulated and analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 39738874Manurung THP, Sitohang IBS, Agustin T. Staphylococcus caprae and Staphylococcus epidermidis define the skin microbiome among different grades of acne vulgaris. Arch Dermatol Res. 2024 Dec 30;317(1):156. doi: 10.1007/s00403-024-03581-1.
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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.
Irma Bernadette Sitohang, MD principal investigator
Faculty of Medicine, University of Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Dr.dr.Irma Bernadette, SpKK (K) at 2 sites 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 4 inclusion and 8 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 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of skin microbiome features on normal and acne vulgaris skin (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838534, which also lists 1 linked publication.
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 1 May 2023.