Baumann Skin Type IndicatorNCT05844904
Mapping of Indonesians' Skin Type Based on Baumann Skin Type Indicator-Indonesia and Development of Artificial Intelligence Modelling
An observational study of Baumann Skin Type Indicator, run by Dr.dr.Irma Bernadette, SpKK (K) at 13 sites in Indonesia.
Trial summary
The goal of this observational study is to learn about the skin type of Indonesians based on Baumann Skin Type Indicator Questionnaire in Indonesian language version, and to develop artificial intelligence modelling of BSTI-Ina. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Baumann Skin Type Indicator
- How many people
- 1,950 participants
- Where
- 13 sitesIndonesia
- Study dates
- 8 Sep 2023to 1 Dec 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: General adult population
Who may be able to join
- Males and females age 18-59 year old.
- Fitzpatrick's skin type III-V
- Educational degree of minimum high school
- Can speak Indonesian
- Can read
- Willing to participate and sign informed consent
Who cannot join
- Participant who doesn't fill the questionnaire completely
- Participant with skin disease involving >25% facial area
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Indonesia13 sites
Rumah Sakit Umum Pusat Dr. Hasan Sadikin
Bandung, West Java, 40161
Rumah Sakit Umum Pusat Prof. Dr. I Goesti Ngoerah Gde Ngoerah
Denpasar, Bali, 80113
Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
Rumah Sakit Umum Pusat Dr. dr. Wahidin Sudirohusodo
Makassar, South Sulawesi, 90245
Rumah Sakit Umum Daerah Dr. Saiful Anwar
Malang, East Java, 65112
Rumah Sakit Umum Pusat Prof. dr. R. D. Kandou
Manado, North Sulawesi, 95262
Rumah Sakit Universitas Sumatera Utara
Medan, North Sumatra, 20154
Rumah Sakit Umum Pusat Dr. M. Djamil
Padang, West Sumatra, 25171
Rumah Sakit Umum Pusat Dr. Mohammad Hoesin
Palembang, South Sumatra, 30126
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Central Java, 50244
Rumah Sakit Umum Daerah Dr. Soetomo
Surabaya, East Java, 60286
Rumah Sakit Umum Daerah Dr. Moewardi
Surakarta, Central Java, 57126
Rumah Sakit Umum Pusat Dr. Sardjito
Yogyakarta, Special Region of Yogyakarta, 55281
About this study
Official title: Mapping of Indonesians' Skin Type Based on Baumann Skin Type Indicator-Indonesia (BSTI-Ina) Questionnaire and Development of Artificial Intelligence Modelling BSTI-Ina: A Multicentric Study
The goal of this observational study is to learn about the skin type of Indonesians based on Baumann Skin Type Indicator Questionnaire in Indonesian language version, and to develop artificial intelligence modelling of BSTI-Ina. The main questions it aims to answer are:
- What is the measurement of the validity and reliability of BSTI-Ina questionnaire year 2006 version which was adapted from BSTI questionnaire in English language year 2006 version as a specific measurement to identify skin type?
- What is the measurement of the validity and reliability of BSTI-Ina questionnaire year 2022 version which was adapted from BSTI questionnaire in English language year 2022 version as a specific measurement to identify skin type?
- What is the comparison of the validity and reliability between BSTI-Ina questionnaire year 2006 and year 2022 to determine Indonesian adult population's skin type?
- How is the mapping of Indonesians' skin type based on BSTI-Ina?
- What is the proportion of each skin type based on BSTI-Ina in Indonesian population?
- What is the proportion of each skin type based on BSTI-Ina in Indonesian population sociodemographically?
- How can Artificial Intelligence help categorize skin type based on BSTI-Ina automatically?
Participants are males and females between 18-59 year old. Participants will be asked to fill BSTI-Ina questionnaire. Participants then will be photographed in five different positions.
Read the detailed description
This research is an observational study with a cross-sectional design. The aims of this study is to determine the validity and reliability of BSTI questionnaire translated in Indonesian and to develop artificial intelligence modelling for BSTI-Ina based on photographs. This study will be held in 13 research centers with a total of 1950 subjects consists of males and females age 18-59. It conducts of 2 phases. Phase 1 is to determine which version of BSTI will be used based on which one is more valid and reliable being translated in Indonesian and will be conducted in Jakarta as a pilot. In phase 1, participants will be asked to fill both BSTI-Ina 2006 and 2002 questionnaire. Participants then will be photographed in five different positions. Data will be analyzed to determine which of BSTI-Ina version is more valid and reliable. After deciding which BSTI-Ina version will be used, the study then goes to phase 2. Phase 2 will be conducted in 12 other research centers in Indonesia to map Indonesian population skin type. In both 2 phases, all participants will be asked to fill in BSTI-Ina questionnaire (either 2006 or 2022 version based on the result of Phase 1). Participants then will be photographed in five different positions. After all the data from all research centers are collected, data will be analyzed to map Indonesian population's skin type. Data as participants' skin types and photographs will also be processed by machine to model artificial intelligence. The aim is to automatically categorize skin type based on BSTI-Ina based on photographs.
- Conditions
- Baumann Skin Type Indicator
- Keywords
- skin type, Baumann Skin Type Indicator, artificial intelligence
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 |
|---|---|---|
| General | This research is an observational study. There's no control and experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baumann Skin Type Indicator questionnaire 2006 version in Indonesian language
Adapting Baumann Skin Type Indicator questionnaire 2006 version to Baumann Skin Type Indicator questionnaire 2006 version in Indonesian language by certified translators
Measured: Up to 2 weeks
Baumann Skin Type Indicator questionnaire 2022 version in Indonesian language
Adapting Baumann Skin Type Indicator questionnaire 2022 version to Baumann Skin Type Indicator questionnaire 2022 version in Indonesian language by certified translators
Measured: Up to 2 weeks
More valid and reliable version of Baumann Skin Type Indicator-Ina questionnaire (2006 or 2022 version)
Comparing between Baumann Skin Type Indicator-Ina questionnaire 2006 version and 2022 version by statistician
Measured: Up to 1 month
Mapping of Indonesian population's skin type based on Baumann Skin Type Indicator-Ina
Determine the proportion of Indonesia population's skin type based on Baumann Skin Type Indicator in 13 research centers
Measured: Up to 2 months
Capability of artificial intelligence model to categorize skin type based on Baumann Skin Type Indicator-Ina
Data such as participants' skin types and photographs will be analyzed by machine resulting AI to categorize skin type automatically by photographs.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 Sep 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baumann Skin Type IndicatorStudies 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
- 1,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesian Society of Dermatology and Venereology, College of Dermatologist and Venereologist, Indonesia Medical Education and Research Institute
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma Bernadette, MD, Principal investigator, Faculty of Medicine, University of IndonesiaHanny Nilasari, MD, Study director, Faculty of Medicine, University of IndonesiaSandra Widaty, MD, Study director, Faculty of Medicine, University of IndonesiaNelva K Jusuf, MD, Study director, Faculty of Medicine, University of North SumatraPuguh Riyanto, MD, Study director, Faculty of Medicine, Diponegoro UniversityAsnawi Madjid, MD, Study director, Faculty of Medicine, Hasanuddin UniversityMarlyn G Kapantow, MD, Study director, Faculty of Medicine, Sam Ratulangi UniversityI Gusti Ayu A Praharsini, MD, Study director, Faculty of Medicine, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844904
- Sponsor's protocol ID
- MappingofBSTI
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of Indonesians' Skin Type Based on Baumann Skin Type Indicator-Indonesia (BSTI-Ina) Questionnaire and Development of Artificial Intelligence Modelling BSTI-Ina: A Multicentric Study
- ClinicalTrials.gov ID
- NCT05844904
- Acronym / sponsor ID
- MappingofBSTI
- Conditions
- Baumann Skin Type Indicator
- Keywords
- skin type, Baumann Skin Type Indicator, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Collaborators
- Indonesian Society of Dermatology and Venereology, College of Dermatologist and Venereologist, Indonesia Medical Education and Research Institute
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 6 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 goal of this observational study is to learn about the skin type of Indonesians based on Baumann Skin Type Indicator Questionnaire in Indonesian language version, and to develop artificial intelligence modelling of BSTI-Ina. The main questions it aims to answer are:
- What is the measurement of the validity and reliability of BSTI-Ina questionnaire year 2006 version which was adapted from BSTI questionnaire in English language year 2006 version as a specific measurement to identify skin type?
- What is the measurement of the validity and reliability of BSTI-Ina questionnaire year 2022 version which was adapted from BSTI questionnaire in English language year 2022 version as a specific measurement to identify skin type?
- What is the comparison of the validity and reliability between BSTI-Ina questionnaire year 2006 and year 2022 to determine Indonesian adult population's skin type?
- How is the mapping of Indonesians' skin type based on BSTI-Ina?
- What is the proportion of each skin type based on BSTI-Ina in Indonesian population?
- What is the proportion of each skin type based on BSTI-Ina in Indonesian population sociodemographically?
- How can Artificial Intelligence help categorize skin type based on BSTI-Ina automatically?
Participants are males and females between 18-59 year old. Participants will be asked to fill BSTI-Ina questionnaire. Participants then will be photographed in five different positions.
Detailed description
This research is an observational study with a cross-sectional design. The aims of this study is to determine the validity and reliability of BSTI questionnaire translated in Indonesian and to develop artificial intelligence modelling for BSTI-Ina based on photographs. This study will be held in 13 research centers with a total of 1950 subjects consists of males and females age 18-59. It conducts of 2 phases. Phase 1 is to determine which version of BSTI will be used based on which one is more valid and reliable being translated in Indonesian and will be conducted in Jakarta as a pilot. In phase 1, participants will be asked to fill both BSTI-Ina 2006 and 2002 questionnaire. Participants then will be photographed in five different positions. Data will be analyzed to determine which of BSTI-Ina version is more valid and reliable. After deciding which BSTI-Ina version will be used, the study then goes to phase 2. Phase 2 will be conducted in 12 other research centers in Indonesia to map Indonesian population skin type. In both 2 phases, all participants will be asked to fill in BSTI-Ina questionnaire (either 2006 or 2022 version based on the result of Phase 1). Participants then will be photographed in five different positions. After all the data from all research centers are collected, data will be analyzed to map Indonesian population's skin type. Data as participants' skin types and photographs will also be processed by machine to model artificial intelligence. The aim is to automatically categorize skin type based on BSTI-Ina based on photographs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General | – | –This research is an observational study. There's no control and experimental group. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General adult population
Key inclusion criteria (6 listed)
- Males and females age 18-59 year old.
- Fitzpatrick's skin type III-V
- Educational degree of minimum high school
- Can speak Indonesian
- Can read
Key exclusion criteria (2 listed)
- Participant who doesn't fill the questionnaire completely
- Participant with skin disease involving >25% facial area
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
Baumann Skin Type Indicator questionnaire 2006 version in Indonesian language
Time frame: Up to 2 weeks
Adapting Baumann Skin Type Indicator questionnaire 2006 version to Baumann Skin Type Indicator questionnaire 2006 version in Indonesian language by certified translators
Baumann Skin Type Indicator questionnaire 2022 version in Indonesian language
Time frame: Up to 2 weeks
Adapting Baumann Skin Type Indicator questionnaire 2022 version to Baumann Skin Type Indicator questionnaire 2022 version in Indonesian language by certified translators
More valid and reliable version of Baumann Skin Type Indicator-Ina questionnaire (2006 or 2022 version)
Time frame: Up to 1 month
Comparing between Baumann Skin Type Indicator-Ina questionnaire 2006 version and 2022 version by statistician
Mapping of Indonesian population's skin type based on Baumann Skin Type Indicator-Ina
Time frame: Up to 2 months
Determine the proportion of Indonesia population's skin type based on Baumann Skin Type Indicator in 13 research centers
Capability of artificial intelligence model to categorize skin type based on Baumann Skin Type Indicator-Ina
Time frame: Up to 1 month
Data such as participants' skin types and photographs will be analyzed by machine resulting AI to categorize skin type automatically by photographs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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, MD principal investigator
Faculty of Medicine, University of Indonesia
Hanny Nilasari, MD study director
Faculty of Medicine, University of Indonesia
Sandra Widaty, MD study director
Faculty of Medicine, University of Indonesia
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Baumann Skin Type Indicator, run by Dr.dr.Irma Bernadette, SpKK (K) at 13 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 6 inclusion and 2 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Baumann Skin Type Indicator questionnaire 2006 version in Indonesian language (time frame: Up to 2 weeks). The study lists 5 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 28 Sep 2023.