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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Condition; Skin Inflammation; Facial Skin Changes
• Intervention / Treatment: Other: Protective facial mask

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • University of Split School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy students of health related professions who wear facial mask daily for at least six hours durnig their internship/practice in health care institutions.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss change	Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).	Weekly measurements for the duration of six weeks
Stratum corneum hydration change	Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).	Weekly measurements for the duration of six weeks
Skin erythema change	Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).	Weekly measurements for the duration of six weeks
Melanin content change	Mexameter will be used to assess skin melanin content. It is a relative measurement and uses arbitrary units (AU).	Weekly measurements for the duration of six weeks
Participants' reported facial skin changes	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.	Weekly measurements for the duration of six weeks
Sebum level changes	Sebumeter will be used to assess sebum levels. It is a relative measurement and uses arbitrary units (AU).	Weekly measurements for the duration of six weeks

Collaborators and Investigators

• Sponsor: University of Split, School of Medicine

Publications and helpful links

General Publications

• Montero-Vilchez T, Cuenca-Barrales C, Martinez-Lopez A, Molina-Leyva A, Arias-Santiago S. Skin adverse events related to personal protective equipment: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2021 Oct;35(10):1994-2006. doi: 10.1111/jdv.17436. Epub 2021 Jun 29.
• Park SR, Han J, Yeon YM, Kang NY, Kim E. Effect of face mask on skin characteristics changes during the COVID-19 pandemic. Skin Res Technol. 2021 Jul;27(4):554-559. doi: 10.1111/srt.12983. Epub 2020 Nov 20.
• Elston DM. Occupational skin disease among health care workers during the coronavirus (COVID-19) epidemic. J Am Acad Dermatol. 2020 May;82(5):1085-1086. doi: 10.1016/j.jaad.2020.03.012. Epub 2020 Mar 18. No abstract available.
• Akl J, El-Kehdy J, Salloum A, Benedetto A, Karam P. Skin disorders associated with the COVID-19 pandemic: A review. J Cosmet Dermatol. 2021 Oct;20(10):3105-3115. doi: 10.1111/jocd.14266. Epub 2021 Jul 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2022
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (ACTUAL): March 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Inflammation; Dermatitis; Skin Diseases; Facies
• Other Study ID Numbers: 2181-198-03-04-22-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No