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临床试验/NCT05277324
NCT05277324Unknown不适用

The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic

University of Split, School of Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Transepidermal water loss change

研究概览

简要总结

The global coronavirus disease pandemic (COVID-19) has led to an increased need to wear protective equipment such as wearing face masks and practicing hygiene measures such as more frequent use of antiseptics. These measures can lead to changes in the skin, the development of new inflammatory skin diseases or exacerbation of existing ones, with health professionals especially under the risk of developing these changes. Changes in facial skin due to wearing masks have been observed in a number of studies, however, part of the study was based solely on subjects' self-assessment or clinical assessment, and only a small part on objective measurements of skin parameters. Also, the impact of prolonged masks' use have not been investigated.

The aim of these study was to investigate the effects of constant, long-term use of protective masks on facial skin.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • young, healthy volunteers who gave written informed consent - students of health related professions who wear facial mask for at least six hours a day durnig their internship/practice in health care institutions

排除标准

  • skin disease, skin damage on measurement sites
  • use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
  • use of emollients three days prior the inclusion in the trial
  • non-adherence to the trial protocol
  • exposure to artificial and excessive natural UV radiation
  • pregnancy and lactation
  • skin cancer
  • immunosuppression

结局指标

主要结局

Transepidermal water loss change

时间窗: Weekly measurements for the duration of six weeks

Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).

Skin erythema change

时间窗: Weekly measurements for the duration of six weeks

Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).

Participants' reported facial skin changes

时间窗: Weekly measurements for the duration of six weeks

Structured interview to determine if participants developed adverse events related to mask wearing (such as dryness, erythema, rash, scaling, pruritus, pain/burning, changes in texture or colour, ulcers etc.) between two measurement time-points.

Stratum corneum hydration change

时间窗: Weekly measurements for the duration of six weeks

Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).

Melanin content change

时间窗: Weekly measurements for the duration of six weeks

Mexameter will be used to assess skin melanin content. It is a relative measurement and uses arbitrary units (AU).

Sebum level changes

时间窗: Weekly measurements for the duration of six weeks

Sebumeter will be used to assess sebum levels. It is a relative measurement and uses arbitrary units (AU).

次要结局

未报告次要终点

研究者

发起方
University of Split, School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dario Leskur

Assistant professor

University of Split, School of Medicine

研究点 (1)

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