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Pandemic, COVID-19NCT06185699

Could Wearing Face Mask Have Affected Demodex Parasite

A study testing standard superficial skin biopsy (SSSB) in people with Pandemic, COVID-19 and Demodex Infestation, run by Nurhan Döner Aktaş at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to examine whether wearing masks by healthy individuals during the Covid-19 pandemic created an environment for Demodex mites, by comparing it with the control group. In order to detect the presence of Demodex mites, standard superficial skin biopsy (SSSB) was applied to the face Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Pandemic, COVID-19, Demodex Infestation
What is being tested?
standard superficial skin biopsy (SSSB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2021to 15 Sep 2021
Phase
Interventional
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 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals (ı) who wore N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hour; (ıı) those who wore a 3-ply surgical mask during all working hours, only took it off for less than 1 hour (ııı) people who wore a 3-ply surgical mask for less than 3 days a week, less than 2 hours a day and spending time mostly at home during the day or plus those who worked alone all day in their rooms and who wear a 3-ply surgical mask for less than 1 hour during the day as required.
  • (The third group represented the control group (the control group was comprised of individuals who presented to the hospital during the study period, since there was no one without mask during the day).

Who cannot join

  • Having dermatosis (acne, acne rosacea, seborrheic dermatitis) and/or other dermatological diseases associated with the presence of Demodex mites, receiving or having been receiving treatment for Demodex-associated dermatosis (topical and/or systemic)
  • Using face wash gel and/or cologne, which prevents the life of Demodex mites, cosmetic cream with pore-clogging feature, applying disinfectant
  • Being obese (BMI> 30)
  • Consuming regular alcohol use,
  • Taking oral therapy that suppresses the immune system, or using creams with immunological effects when applied topically on the face
  • Developing any skin complaints with wearing masks.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Katip Çelebi University Atatürk Research and Trainig Hospital

    Izmir, 35000

Other trials in Turkey (Türkiye)

About this study

Official title: Could Wearing Face Mask During the Pandemic Have Created An Environment for Demodex Mites?

This study aimed to examine whether wearing masks by healthy individuals during the Covid-19 pandemic created an environment for Demodex mites, by comparing it with the control group. In order to detect the presence of Demodex mites, standard superficial skin biopsy (SSSB) was applied to the face

Read the detailed description

The study was carried out on March 15.2021 and the data collection was completed within 6 months. For the randomization of the participants, they were first stratified according to age and then the participants were selected according to the simple randomization table and included in the study.The sample of the study was calculated to be at least 48 people for each group, with the power of the test being approximately 80,151%. Ethics committee approval of the study was obtained from the clinical research ethics committee of Katip Çelebi University with no: 27 on 11.03.2021. A total of 144 people who met the inclusion criteria, 48 individuals for each group, were included in the study. The study was conducted in accordance with the principles of the Declaration of Helsinki. Participants were included in the study after signing the informed consent form. The exclusion criteria included having dermatosis (acne, acne rosacea, seborrheic dermatitis) and/or other dermatological diseases associated with the presence of Demodex mites, receiving or having been receiving treatment for Demodex-associated dermatosis (topical and/or systemic), using face wash gel and/or cologne, which prevents the life of Demodex mites, cosmetic cream with pore-clogging feature, applying disinfectant; being obese (BMI> 30), consuming regular alcohol use, and taking oral therapy that suppresses the immune system, or using creams with immunological effects when applied topically on the face as well as developing any skin complaints with wearing masks, Individuals who wore N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hour; (ıı) those who wore a 3-ply surgical mask during all working hours, only took it off for less than 1 hour and (ııı) people who wore a 3-ply surgical mask for less than 3 days a week, less than 2 hours a day and spending time mostly at home during the day or plus those who worked alone all day in their rooms and who wear a 3-ply surgical mask for less than 1 hour during the day as required. The third group represented the control group (the control group was comprised of individuals who presented to the hospital during the study period, since there was no one without mask during the day). Participants were included in the study after signing the informed consent form. The sociodemographic characteristics, including age, gender and occupation; cigarette use, alcohol use, the past medical history, face washing habits (only water, water and soap, non-specific face wash product) and dermatological examination, whether the skin is oily or dry-normal, and Fitzpatrick skin typing were determined. In order to detect the presence of Demodex mites, standard superficial skin biopsy (SSSB) was applied to the face that was wiped with dry sterile gauze after dropping cyanoacrylate by marking 1 cm2 area on the slide that was wiped with dry sterile gauze from 3 areas of the face, right cheek, nose and the mid-forehead. After the slide was left for 60 seconds and slowly removed from the face, immersion oil was dripped onto the slide and covered with a coverslip, and Demodex mites were counted first under the light microscope at x10 and then x20 magnification (Demodex foliculorum and brevis were not differentiated). The process was repeated for each region. The presence of Demodex mites in each region and its number, if any, were written on the inquiry form.

Being tested
standard superficial skin biopsy (SSSB)
Keywords
Covid-19, demodex, mask
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard superficial skin biopsy (SSSB)Diagnostic test

    standard superficial skin biopsy (SSSB) was applied to the face that was wiped with dry sterile gauze after dropping cyanoacrylate by marking 1 cm2 area on the slide that was wiped with dry sterile gauze from 3 areas of the face, right cheek, nose and the mid-forehead. After the slide was left for 60 seconds and slowly removed from the face, immersion oil was dripped onto the slide and covered with a coverslip, and Demodex mites were counted first under the light microscope at x10 and then x20 magnification (Demodex foliculorum and brevis were not differentiated). The process was repeated for each region.

Study groups in NCT06185699
Study groupRoleWhat they receive
N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hourOtherIndividuals (ı) who wore N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hour. In order to detect the presence of Demodex mites, standard superficial skin biopsy (SSSB) was applied
Receives: Diagnostic Test: standard superficial skin biopsy (SSSB)
3-ply surgical mask during all working hours, only took it off for less than 1 hourOtherIndividuals who wore a 3-ply surgical mask during all working hours, only took it off for less than 1 hour.In order to detect the presence of Demodex mites, standard superficial skin biopsy (SSSB) was applied
Receives: Diagnostic Test: standard superficial skin biopsy (SSSB)
control (who rarely used masks under pandemic conditions)Otherpeople who wore a 3-ply surgical mask for less than 3 days a week, less than 2 hours a day and spending time mostly at home during the day or plus those who worked alone all day in their rooms and who wear a 3-ply surgical mask for less than 1 hour during the day as required. In order to detect the presence of Demodex mites, standard superficial skin biopsy (SSSB) was applied
Receives: Diagnostic Test: standard superficial skin biopsy (SSSB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. presence of demodex mites

    The presence of Demodex mites was detected by the standard superficial skin biopsy (SSSB) from 3 regions of the face ( the right cheek, the nose, the mid-forehead).

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2023
  2. Study start15 Mar 2021
  3. Primary completion15 Sep 2021
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Individuals (ı) who wore N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hour; (ıı) those who wore a 3-ply surgical mask during all working hours, only took it off for less than 1 hour and (ııı) people who wore a 3-ply surgical mask for less than 3 days a week, less than 2 hours a day and spending time mostly at home during the day or plus those who worked alone all day in their rooms and who wear a 3-ply surgical mask for less than 1 hour during the day as required.
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06185699
Sponsor's protocol ID
2021-KAE-0023
Status last verified
Dec 2023
First submitted
1 Dec 2023
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing standard superficial skin biopsy (SSSB) in people with Pandemic, COVID-19 and Demodex Infestation, run by Nurhan Döner Aktaş at 1 site in Turkey (Türkiye).

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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Dec 2023. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of demodex mites (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Dec 2023.

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