Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

Acne Vulgaris Clinical Trial

Official title:

Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05838534
• Other study ID #: SkinMicrobiomeComparison
• Status: Active, not recruiting
• Start date: January 17, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: April 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: May 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Locations

Country	Name	City	State
Indonesia	Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia	Jakarta Pusat	DKI Jakarta
Indonesia	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr.dr.Irma Bernadette, SpKK (K)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of skin microbiome features on normal and acne vulgaris skin	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