Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients

Dr.dr.Irma Bernadette, SpKK (K)

Status: Active, not recruiting

Conditions: Acne Vulgaris

Study type: Observational

Funder types: Other

Identifiers

NCT05838534

SkinMicrobiomeComparison

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

144 participants in 4 patient groups

Normal Skin

Mild Acne Vulgaris

Moderate Acne Vulgaris

Severe Acne Vulgaris