Clinical Characteristics and Longitudinal Changes in the Facial Skin Microbiome of Patients With Moderate-to-Severe Acne Vulgaris Treated With Isotretinoin: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Shannon-Wiener Diversity Index of the Facial Skin Microbiome at Baseline
研究概览
简要总结
Acne vulgaris is associated with changes in the facial skin microbiome, but longitudinal microbiome changes during isotretinoin therapy remain incompletely understood. This prospective observational cohort study aims to characterize the facial skin microbiome in patients with moderate-to-severe acne vulgaris before and during isotretinoin treatment and to compare microbiome profiles with healthy individuals.
Participants with moderate-to-severe acne vulgaris receiving standard-of-care oral isotretinoin will be followed prospectively. Facial skin swab samples will be collected before treatment and at scheduled follow-up visits during therapy. Healthy volunteers without acne will provide a single facial skin swab for comparison. Bacterial communities will be analyzed using 16S rRNA gene sequencing, and clinical severity will be assessed using validated acne severity scores and lesion counts.
The study will evaluate changes in microbial diversity, bacterial composition, and the relative abundance of acne-associated microorganisms during isotretinoin treatment. Associations between microbiome changes and clinical improvement will also be explored. Results are expected to improve understanding of the role of the skin microbiome in acne and provide evidence for future microbiome-based therapeutic strategies.
详细描述
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit and is one of the most common dermatologic disorders worldwide. Increasing evidence suggests that acne is associated with alterations in the composition and diversity of the skin microbiome rather than the presence of a single pathogenic microorganism. However, longitudinal changes in the facial skin microbiome during isotretinoin treatment have not been fully characterized in Southeast Asian populations.
This study is a prospective observational cohort conducted in Vietnam. The study includes two participant groups: patients with moderate-to-severe acne vulgaris and healthy volunteers without acne. Patients receive oral isotretinoin according to routine clinical practice and institutional treatment protocols. The study does not assign or modify treatment; investigators prospectively observe clinical and microbiome changes during routine care.
Facial skin samples are collected using standardized skin swab procedures from predefined facial sites. Samples are processed for bacterial DNA extraction and 16S rRNA gene sequencing to characterize microbial communities. Sequencing data are analyzed using bioinformatics pipelines for taxonomic classification and diversity analysis.
Clinical assessments include validated acne severity grading systems, inflammatory and non-inflammatory lesion counts, and evaluation of treatment response during follow-up. Healthy volunteers provide baseline microbiome samples for comparison with acne participants before treatment.
The primary objective is to characterize longitudinal changes in the facial skin microbiome during isotretinoin treatment in patients with moderate-to-severe acne vulgaris. Secondary objectives include comparing baseline microbiome characteristics between acne patients and healthy individuals and exploring associations between microbiome composition and clinical treatment outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acne Vulgaris Cohort:
- •Participants aged 12-35 years.
- •Clinical diagnosis of acne vulgaris.
- •Presence of acne lesions on both cheeks.
- •Indication for oral isotretinoin treatment according to clinical assessment at Can Tho University of Medicine and Pharmacy Hospital.
- •Willingness to participate in the study.
- •Healthy Control Cohort:
- •Voluntary participation in the study.
- •No history or clinical manifestations of acne vulgaris.
- •No use of antibiotics or isotretinoin within the previous 6 months.
- •No lesions of other skin diseases on the face.
排除标准
- •Current dermatologic diseases such as rosacea, contact dermatitis, eczema, or psoriasis.
- •Current acute or chronic medical diseases.
- •Use of antibiotics or isotretinoin within the previous 3 months.
- •Use of phototherapy or topical probiotics on the facial skin within the previous 3 months.
- •Use of facial cleansing products or topical medications within 24 hours before sample collection.
- •History of allergy.
- •Unwillingness to participate in the study.
研究组 & 干预措施
Healthy Control Cohort
Healthy volunteers without acne vulgaris who provide baseline facial skin samples for comparison with the acne vulgaris cohort.
Acne Vulgaris Cohort
Participants with moderate-to-severe acne vulgaris who are receiving oral isotretinoin as part of routine clinical care and are followed prospectively for clinical and facial skin microbiome changes
干预措施: ISOtretinoin 10 MG (Drug)
结局指标
主要结局
Shannon-Wiener Diversity Index of the Facial Skin Microbiome at Baseline
时间窗: At baseline, before isotretinoin treatment in the acne cohort
Difference in the Shannon-Wiener diversity index of the facial skin microbiome between participants with moderate-to-severe acne vulgaris and healthy controls at baseline.
Change in Shannon-Wiener Diversity Index of the Facial Skin Microbiome During Isotretinoin Treatment
时间窗: Baseline to Week 20
Change in the Shannon-Wiener diversity index of the facial skin microbiome from baseline to after 20 weeks of isotretinoin treatment in participants with moderate-to-severe acne vulgaris.
次要结局
- Relative Abundance and Taxonomic Composition of the Facial Skin Microbiome(Baseline)
- Alpha Diversity of the Facial Skin Microbiome(Baseline)
- Beta Diversity of the Facial Skin Microbiome(Baseline)
- Change in Bacterial Community Composition During Isotretinoin Treatment(Baseline to Week 20)
- Change in Alpha Diversity During Isotretinoin Treatment(Baseline to Week 12)
- Change in Beta Diversity During Isotretinoin Treatment(Baseline to Week 20)
- Clinical Response to Isotretinoin at Week 20(Baseline to Week 20)