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).
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
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.
- Conditions
- Pandemic, COVID-19, Demodex Infestation
- 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 group | Role | What they receive |
|---|---|---|
| N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hour | Other | Individuals (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 hour | Other | Individuals 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) | Other | 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. 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.
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.
- First posted29 Dec 2023
- Study start15 Mar 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pandemic, COVID-19Studies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Nurhan Döner Aktaş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurhan Döner Aktaş, Izmir Katip Celebi University
- Investigators
- Nurhan Döner Aktaş, Specialist, Principal investigator, Izmir Katip Celebi University Atatürk Research and Training Hospital dermatology Department
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Wearing Face Mask During the Pandemic Have Created An Environment for Demodex Mites?
- ClinicalTrials.gov ID
- NCT06185699
- Acronym / sponsor ID
- 2021-KAE-0023
- Conditions
- Pandemic, COVID-19, Demodex Infestation
- Keywords
- Covid-19, demodex, mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Nurhan Döner AktaşUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 29 Dec 2023 (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.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hour | Other | Diagnostic Test: standard superficial skin biopsy (SSSB)Individuals (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 |
| 3-ply surgical mask during all working hours, only took it off for less than 1 hour | Other | Diagnostic Test: standard superficial skin biopsy (SSSB)Individuals 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 |
| control (who rarely used masks under pandemic conditions) | Other | Diagnostic Test: standard superficial skin biopsy (SSSB)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. In order to detect the presence of Demodex mites, standard superficial skin biopsy (SSSB) was applied |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| standard superficial skin biopsy (SSSB)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. | Diagnostic test | 3-ply surgical mask during all working hours, only took it off for less than 1 hour, N95/FFP2 masks during the whole working hours, and only took off it for less than 1 hour, control (who rarely used masks under pandemic conditions) |
Primary outcome
presence of demodex mites
Time frame: 6 month
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Nurhan Döner Aktaş, Specialist principal investigator
Izmir Katip Celebi University Atatürk Research and Training Hospital dermatology Department
1 site in 1 country: see every site and its status.
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.