Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

Sponsor
Dr.dr.Irma Bernadette, SpKK (K) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05838534
Collaborator
(none)
144
2
4.2
72
17.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    144 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients
    Actual Study Start Date :
    Jan 17, 2023
    Actual Primary Completion Date :
    Mar 24, 2023
    Anticipated Study Completion Date :
    May 24, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Normal Skin

    Mild Acne Vulgaris

    Moderate Acne Vulgaris

    Severe Acne Vulgaris

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of skin microbiome features on normal and acne vulgaris skin [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia Jakarta Pusat DKI Jakarta Indonesia 10430
    2 Dr. Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Dr.dr.Irma Bernadette, SpKK (K)

    Investigators

    • Principal Investigator: Irma Bernadette Sitohang, MD, Faculty of Medicine, University of Indonesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr.dr.Irma Bernadette, SpKK (K), Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05838534
    Other Study ID Numbers:
    • SkinMicrobiomeComparison
    First Posted:
    May 1, 2023
    Last Update Posted:
    May 1, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr.dr.Irma Bernadette, SpKK (K), Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Indonesia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2023