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

• Conditions: Skin Condition; Facial Skin Changes; Skin Inflammation

• Registration Number: NCT05277324
• Lead Sponsor: University of Split, School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-07
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-11
• Last Update Submitted: 2022-03-13
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss change	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	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	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	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	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	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).

Trial Locations

Locations (1)

University of Split School of Medicine; 🇭🇷 Split, Croatia