Clinical trial NCT05277324: The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic
Official title: The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Condition
Skin Inflammation
Facial Skin Changes
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transepidermal water loss change
timeFrame: Weekly measurements for the duration of six weeks
measure: Stratum corneum hydration change
timeFrame: Weekly measurements for the duration of six weeks
measure: Skin erythema change
timeFrame: Weekly measurements for the duration of six weeks
measure: Melanin content change
timeFrame: Weekly measurements for the duration of six weeks
measure: Participants' reported facial skin changes
timeFrame: Weekly measurements for the duration of six weeks
measure: Sebum level changes
timeFrame: Weekly measurements for the duration of six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
References:
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.
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.
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. No abstract available.
citation: 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.