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临床试验/NCT04476732
NCT04476732已完成不适用

Interactions Between Skincare Product Ingredients and the Skin Microbiome

University of California, Davis2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年2月11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
19
试验地点
2
主要终点
Change in detected paraben levels

研究概览

简要总结

This is a study of the influence of skincare products containing chemicals such as parabens and phthalates on the skin microbiome.

详细描述

Skin serves as a critical barrier between our bodies and the environment and the locus for a diverse and active microbial community. The composition and metabolic activity of the microbial community on the skin is presumably influenced by the local chemical environment, which includes natural skin lipids (e.g., squalene and sapienic acid), components of personal care products applied directly to skin, and semi-volatile organic compounds (SVOCs) that reach the skin through gas phase absorption, dust deposition, and direct contact with surfaces. Common semi-volatile ingredients in skin care products include phthalates, parabens, and UV blocking compounds (e.g., oxybenzone, octocrylene or homosalate).

The investigators have recently demonstrated a method of collecting chemicals from areas of skin with infrequent direct dermal contact using alcohol wipes to assess passive air to skin partitioning of both target and nontarget compounds (Garrido et al., in review). Low-volatility reaction products can accumulate in skin oils and act as skin irritants, with the potential of being absorbed into the bloodstream. With methods developed for chemical and microbiome sampling, the overall goal of the proposed research is to develop an understanding of the two-way interaction between organic chemicals on the skin and the composition of the skin microbiome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Individuals aged 15 and over
  • No known medical conditions that, in the investigator's opinion, may interfere with study participation.

排除标准

  • Individuals who have been on any medication (including antibiotics, probiotics, prebiotics) that has caused a change in current skin composition of interest based on the opinion of the investigator.
  • Individuals with systemic antibiotic use within last 60 days.
  • Individuals with topical antibiotic use on the test sites within last 30 days
  • Individuals unwilling/unable to avoid topical antibiotics, systemic antibiotics, prebiotics, and probiotics during study.
  • No other interfering skin products should be used during duration of study. (Paraben-free & phthalate-free personal product "safe" list will be provided for other uses during study period if needed).
  • Individuals unwilling or unable to undergo 1 week wash-in with paraben/phthalate-free products if needed in the opinion of the investigator.
  • Female volunteers who are pregnant or are actively breastfeeding or planning a pregnancy within two months. (There is no known concern for risk to fetus but pregnancy can alter the microbiome being studied)
  • Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days
  • Individuals using any interfering skin products in the opinion of the investigator within 2 weeks of enrollment into the study.
  • Individuals who have participated in any other clinical studies using the same test sites (face) in the past 14 days
  • Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
  • Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.

结局指标

主要结局

Change in detected paraben levels

时间窗: Baseline, 1 week, 2 weeks

Demonstrate the ability to detect chemicals (specifically parabens) found in common ingredients in personal care products on human skin. Collection of isopropyl alcohol forehead wipe and subsequent detection and quantification of parabens by GC-QTOF-MS (gas chromatography) and LC-QTOF-MS (liquid chromatography). Comparisons between baseline, week 1, and week 2 will be made.

次要结局

  • Influence of skincare product ingredient (specifically parabens) on facial skin microbiome(Baseline, 1 week, 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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