NCT05844904

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. 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. 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. 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. 4.How is the mapping of Indonesians' skin type based on BSTI-Ina?
  5. 5.What is the proportion of each skin type based on BSTI-Ina in Indonesian population?
  6. 6.What is the proportion of each skin type based on BSTI-Ina in Indonesian population sociodemographically?
  7. 7.How can Artificial Intelligence help categorize skin type based on BSTI-Ina automatically?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

April 5, 2023

Last Update Submit

September 26, 2023

Conditions

Keywords

skin typeBaumann Skin Type Indicatorartificial intelligence

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

    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.

    Up to 1 month

Study Arms (1)

General

This research is an observational study. There's no control and experimental group.

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

General adult population

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Rumah Sakit Umum Pusat Prof. Dr. I Goesti Ngoerah Gde Ngoerah

Denpasar, Bali, 80113, Indonesia

Location

Rumah Sakit Umum Pusat Dr. Kariadi

Semarang, Central Java, 50244, Indonesia

Location

Rumah Sakit Umum Daerah Dr. Moewardi

Surakarta, Central Java, 57126, Indonesia

Location

Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Rumah Sakit Umum Daerah Dr. Saiful Anwar

Malang, East Java, 65112, Indonesia

Location

Rumah Sakit Umum Daerah Dr. Soetomo

Surabaya, East Java, 60286, Indonesia

Location

Rumah Sakit Umum Pusat Prof. dr. R. D. Kandou

Manado, North Sulawesi, 95262, Indonesia

Location

Rumah Sakit Universitas Sumatera Utara

Medan, North Sumatra, 20154, Indonesia

Location

Rumah Sakit Umum Pusat Dr. dr. Wahidin Sudirohusodo

Makassar, South Sulawesi, 90245, Indonesia

Location

Rumah Sakit Umum Pusat Dr. Mohammad Hoesin

Palembang, South Sumatra, 30126, Indonesia

Location

Rumah Sakit Umum Pusat Dr. Sardjito

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Location

Rumah Sakit Umum Pusat Dr. Hasan Sadikin

Bandung, West Java, 40161, Indonesia

Location

Rumah Sakit Umum Pusat Dr. M. Djamil

Padang, West Sumatra, 25171, Indonesia

Location

Study Officials

  • Irma Bernadette, MD

    Faculty of Medicine, University of Indonesia

    PRINCIPAL INVESTIGATOR
  • Hanny Nilasari, MD

    Faculty of Medicine, University of Indonesia

    STUDY DIRECTOR
  • Sandra Widaty, MD

    Faculty of Medicine, University of Indonesia

    STUDY DIRECTOR
  • Nelva K Jusuf, MD

    Faculty of Medicine, University of North Sumatra

    STUDY DIRECTOR
  • Puguh Riyanto, MD

    Faculty of Medicine, Diponegoro University

    STUDY DIRECTOR
  • Asnawi Madjid, MD

    Faculty of Medicine, Hasanuddin University

    STUDY DIRECTOR
  • Marlyn G Kapantow, MD

    Faculty of Medicine, Sam Ratulangi University

    STUDY DIRECTOR
  • I Gusti Ayu A Praharsini, MD

    Faculty of Medicine, Udayana University

    STUDY DIRECTOR
  • Reti Hindritiani, MD

    Faculty of Medicine, Padjadjaran University

    STUDY DIRECTOR
  • Diah M Indramaya, MD

    Faculty of Medicine, Airlangga University

    STUDY DIRECTOR
  • Yuli Kurniawati, MD

    Faculty of Medicine, Sriwijaya University

    STUDY DIRECTOR
  • Satya W Yenny, MD

    Faculty of Medicine, Andalas University

    STUDY DIRECTOR
  • Arie Kusumawardani, MD

    Faculty of Medicine, Sebelas Maret University

    STUDY DIRECTOR
  • Shinta Murlistyarini, MD

    Faculty of Medicine, Brawijaya University

    STUDY DIRECTOR
  • Flandiana Yogianti, MD

    Faculty of Medicine, Gadjah Mada University

    STUDY DIRECTOR
  • Aria Kekalih, MD

    Faculty of Medicine, University of Indonesia

    STUDY DIRECTOR
  • Prasandhya A Yusuf, PhD

    Indonesia Medical Education and Research Institute, University of Indonesia

    STUDY DIRECTOR
  • Eric D Tenda, MD

    Indonesia Medical Education and Research Institute, University of Indonesia

    STUDY DIRECTOR
  • Vanya V Valindria, PhD

    Indonesia Medical Education and Research Institute, University of Indonesia

    STUDY DIRECTOR
  • Sari Chairunnisa, MD

    Paragon Technology & Innovation

    STUDY DIRECTOR
  • Irwan Batubara, MD

    Faculty of Medicine, University of Indonesia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) - Head of Cosmetic Dermatology Division, Dermatology and Venereology Department, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 6, 2023

Study Start

September 8, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations