Clinical trial NCT05844904: Mapping of Indonesians' Skin Type Based on Baumann Skin Type Indicator-Indonesia and Development of Artificial Intelligence Modelling
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Baumann Skin Type Indicator
Keywords: skin type
Baumann Skin Type Indicator
artificial intelligence
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Indonesian Society of Dermatology and Venereology
name: College of Dermatologist and Venereologist
name: Indonesia Medical Education and Research Institute
First posted: 2023-05-06
Enrollment: 1950
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General adult population

Brief 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. 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?
2. 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?
3. 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?
4. How is the mapping of Indonesians' skin type based on BSTI-Ina?
5. What is the proportion of each skin type based on BSTI-Ina in Indonesian population?
6. What is the proportion of each skin type based on BSTI-Ina in Indonesian population sociodemographically?
7. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participant who doesn't fill the questionnaire completely
* Participant with skin disease involving \>25% facial area

Primary outcomes:
measure: Baumann Skin Type Indicator questionnaire 2006 version in Indonesian language
timeFrame: Up to 2 weeks
measure: Baumann Skin Type Indicator questionnaire 2022 version in Indonesian language
timeFrame: Up to 2 weeks
measure: More valid and reliable version of Baumann Skin Type Indicator-Ina questionnaire (2006 or 2022 version)
timeFrame: Up to 1 month
measure: Mapping of Indonesian population's skin type based on Baumann Skin Type Indicator-Ina
timeFrame: Up to 2 months
measure: Capability of artificial intelligence model to categorize skin type based on Baumann Skin Type Indicator-Ina
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Rumah Sakit Umum Pusat Prof. Dr. I Goesti Ngoerah Gde Ngoerah
state: Bali
city: Semarang
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. Kariadi
state: Central Java
city: Surakarta
country: Indonesia
facility: Rumah Sakit Umum Daerah Dr. Moewardi
state: Central Java
city: Jakarta Pusat
country: Indonesia
facility: Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
state: DKI Jakarta
city: Malang
country: Indonesia
facility: Rumah Sakit Umum Daerah Dr. Saiful Anwar
state: East Java
city: Surabaya
country: Indonesia
facility: Rumah Sakit Umum Daerah Dr. Soetomo
state: East Java
city: Manado
country: Indonesia
facility: Rumah Sakit Umum Pusat Prof. dr. R. D. Kandou
state: North Sulawesi
city: Medan
country: Indonesia
facility: Rumah Sakit Universitas Sumatera Utara
state: North Sumatra
city: Makassar
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. dr. Wahidin Sudirohusodo
state: South Sulawesi
city: Palembang
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. Mohammad Hoesin
state: South Sumatra
city: Yogyakarta
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. Sardjito
state: Special Region Of Yogyakarta
city: Bandung
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. Hasan Sadikin
state: West Java
city: Padang
country: Indonesia
facility: Rumah Sakit Umum Pusat Dr. M. Djamil
state: West Sumatra
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Irma Bernadette, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Indonesia
name: Hanny Nilasari, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, University of Indonesia
name: Sandra Widaty, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, University of North Sumatra
name: Nelva K Jusuf, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Diponegoro University
name: Puguh Riyanto, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Hasanuddin University
name: Asnawi Madjid, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Sam Ratulangi University
name: Marlyn G Kapantow, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Udayana University
name: I Gusti Ayu A Praharsini, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Padjadjaran University
name: Reti Hindritiani, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Airlangga University
name: Diah M Indramaya, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Sriwijaya University
name: Yuli Kurniawati, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Andalas University
name: Satya W Yenny, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Sebelas Maret University
name: Arie Kusumawardani, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Brawijaya University
name: Shinta Murlistyarini, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Gadjah Mada University
name: Flandiana Yogianti, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, University of Indonesia
name: Aria Kekalih, MD
role: STUDY_DIRECTOR
affiliation: Indonesia Medical Education and Research Institute, University of Indonesia
name: Prasandhya A Yusuf, PhD
role: STUDY_DIRECTOR
affiliation: Indonesia Medical Education and Research Institute, University of Indonesia
name: Eric D Tenda, MD
role: STUDY_DIRECTOR
affiliation: Indonesia Medical Education and Research Institute, University of Indonesia
name: Vanya V Valindria, PhD
role: STUDY_DIRECTOR
affiliation: Paragon Technology & Innovation
name: Sari Chairunnisa, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, University of Indonesia
name: Irwan Batubara, MD
role: STUDY_DIRECTOR
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