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

NCT05277324 | Unknown

• 1 other identifier: 2181-198-03-04-22-0010
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Condition; Skin Inflammation; Facial Skin Changes

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Protective facial mask OTHER

Participants, students of health related professions, who wear protective facial mask daily during their internship/practice in health institutions.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• skin disease, skin damage on measurement sites
• non-adherence to the trial protocol
• exposure to artificial and excessive natural UV radiation
• pregnancy and lactation
• skin cancer
• immunosuppression

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

RECRUITING

Related Publications (4)

• 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.

  PMID: 34077565 BACKGROUND

• 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.

  PMID: 33217053 BACKGROUND

• 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.

  PMID: 32171807 BACKGROUND

• 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.

  PMID: 34077629 BACKGROUND

MeSH Terms

Conditions

Skin Diseases; Dermatitis

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Central Study Contacts

Dario Leskur, PhD, MPharm

CONTACT

+38521557851; dario.leskur@mefst.hr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 14, 2022
• Study Start: March 7, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

CR (1)