Skin ConditionNCT05277324
The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic
An observational study of Skin Condition and Skin Inflammation, run by University of Split, School of Medicine at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Condition, Skin Inflammation, Facial Skin Changes
- What is being tested?
- Protective facial mask
- How many people
- 20 participants
- Where
- 1 siteCroatia
- Study dates
- 7 Mar 2022to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of Medicine
Split, 21000
Dario Leskur, PhD, MPharm, +38521557851, dario.leskur@mefst.hr
About this study
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
- Being tested
- Protective facial mask
- Medical subject headings
- Skin Diseases, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective facial maskOther
Participants, students of health related professions, who wear protective facial mask daily during their internship/practice in health institutions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss change
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Weekly measurements for the duration of six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start7 Mar 2022
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Leskur, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277324
- Sponsor's protocol ID
- 2181-198-03-04-22-0010
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34077565Park 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.
PubMed 33217053Elston 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.
PubMed 32171807Akl 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.
PubMed 34077629
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wearing Facial Masks on Skin Parameters During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05277324
- Acronym / sponsor ID
- 2181-198-03-04-22-0010
- Conditions
- Skin Condition, Skin Inflammation, Facial Skin Changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective facial maskParticipants, students of health related professions, who wear protective facial mask daily during their internship/practice in health institutions. | Other | – |
Primary outcome
Transepidermal water loss change
Time frame: 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).
Stratum corneum hydration change
Time frame: 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).
Skin erythema change
Time frame: 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).
Melanin content change
Time frame: 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).
Participants' reported facial skin changes
Time frame: 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.
Sebum level changes
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 34077565Montero-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.
- Background: PubMed 33217053Park 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.
- Background: PubMed 32171807Elston 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.
- Background: PubMed 34077629Akl 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Condition and Skin Inflammation, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dario Leskur, PhD, MPharm (+38521557851, dario.leskur@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal water loss change (time frame: Weekly measurements for the duration of six weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277324, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.