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

Skin Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277324
• Other study ID #: 2181-198-03-04-22-0010
• Status: Recruiting
• Start date: March 7, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2022
• Source: University of Split, School of Medicine
• Contact: Dario Leskur, PhD, MPharm
• Phone: +38521557851
• Email: dario.leskur[@]mefst.hr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Dermatitis
• Facies
• Inflammation
• Skin Condition
• Skin Diseases
• Skin Inflammation

Intervention

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

Locations

Country	Name	City	State
Croatia	University of Split School of Medicine	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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