Clinical trial NCT05838534: Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients
Official title: Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acne Vulgaris
Keywords: Skin Microbiome
Normal Skin
Acne Vulgaris
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female, 18-40 years old, normal skin, diagnosed with mild to severe acne

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of skin microbiome features on normal and acne vulgaris skin
timeFrame: up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia
state: DKI Jakarta
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Irma Bernadette Sitohang, MD
role: PRINCIPAL_INVESTIGATOR
References: