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临床试验/NCT04367584
NCT04367584已完成不适用

Comparison of Malassezia Spp Proportions in Inflammatory and Non Inflammatory Facial Acne Vulgaris Lesions

Indonesia University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Proportion of Malassezia spp. from culture examination

研究概览

简要总结

Acne vulgaris (AV) is a common inflammatory condition involving pilosebaceous unit. The pathogenesis of acne is multifactorial and skin microbiome is considered to be one of the key factors that aggravate inflammation. Malassezia spp is normal flora on the skin and several studies have reported its corelation with inflammatory AV lesion.

Malassezia have higher lipase activity compared to Propionibacterium acnes which triggers an increase in free fatty acid and glycerol, the chemotactic factors towards neutrophils and inducing inflammation in AV. Malassezia folliculitis (MF) is sometimes confused with and may present together with AV. Pruritus usually presents in MF but some studies also reported itching as common symptom in AV.

The objectives of this study were to identify the presence and the distribution of Malassezia spp. in facial AV lesions, to compare the distribution of Malassezia spp. between inflammatory and non-inflammatory lesions and to identify the association between Malassezia spp in acne lesions and pruritus symptom.

详细描述

This study used cross sectional design study.

Subjects with eligible criteria were included. Subjects were divided into subjects with inflammatory lesions and subjects with non inflammatory lesions.

Physical examination consisted of assesment of AV severity (using Lehman criteria) and presence of pruritus based on visual analog scale. Clinical documetations were taken.

Follicular content of four inflammatory lesions or four non inflammatory lesions were collected for microscopic examination with KOH solution and fungal culture examination (using CHROMagar Malassezia, Dextrose Saboraud agar (DSA), and Tween 60-esculin agar).

The presence of Malassezia spp and its spore load in both groups were assesed and analyzed for its corelation with AV severity and presence of pruritus.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with age of 15-49 years with AV and the presence of at least four inflammatory and four non-inflammatory lesions

排除标准

  • Subjects with prior topical retinoid acid or topical antifungal medication within the past two weeks, systemic antibiotic or antifungal use within the past month, and corticosteroid use within the past six months

结局指标

主要结局

Proportion of Malassezia spp. from culture examination

时间窗: Sample collected during subjects enrollment

Proportion of Malassezia spp. from culture of inflammatory and non-inflammatory facial AV lesions

次要结局

  • Proportion of fungal spore load based on microscopic examination(Sample collected during subjects enrollment)
  • Presence and severity of pruritus(Data collected during subjects enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Agassi Suseno Sutarjo, SpKK

Principal investigator

Indonesia University

研究点 (1)

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