Microbiome Comparison Profile of Normal Skin and Acne Vulgaris Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Comparison of skin microbiome features on normal and acne vulgaris skin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Comparison of skin microbiome features on normal and acne vulgaris skin
时间窗: 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.
次要结局
未报告次要终点
研究者
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