Could Wearing Face Mask Have Affected Demodex Parasite

NCT06185699 | Completed

• 1 other identifier: 2021-KAE-0023
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pandemic, COVID-19; Demodex Infestation

Keywords

Covid-19; demodex; mask

Outcome Measures

Primary Outcomes (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).

  6 month

Study Arms (3)

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

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

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

Diagnostic Test: standard superficial skin biopsy (SSSB)

Interventions

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.

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)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nurhan Döner Aktaş: lead

Study Sites (1)

Izmir Katip Çelebi University Atatürk Research and Trainig Hospital

Izmir, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nurhan Döner Aktaş, Specialist

  Izmir Katip Celebi University Atatürk Research and Training Hospital dermatology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dermatology specialist, principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 29, 2023
• Study Start: March 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)