Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

April 28, 2023 updated by: Dr.dr.Irma Bernadette, SpKK (K)
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Dr. Cipto Mangunkusumo Hospital
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Male or female, 18-40 years old, normal skin, diagnosed with mild to severe acne

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal Skin
Mild Acne Vulgaris
Moderate Acne Vulgaris
Severe Acne Vulgaris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Actual)

March 24, 2023

Study Completion (Anticipated)

May 24, 2023

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SkinMicrobiomeComparison

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe