Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185699
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2023-12-01
Brief Title:
Could Wearing Face Mask Have Affected Demodex Parasite
Sponsor:
Nurhan Döner Aktaş
Organization:
Izmir Katip Celebi University
Study Overview
Official Title:
Could Wearing Face Mask During the Pandemic Have Created An Environment for Demodex Mites
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The study was carried out on March 152021 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 studyThe sample of the study was calculated to be at least 48 people for each group with the power of the test being approximately 80151 Ethics committee approval of the study was obtained from the clinical research ethics committee of Katip Çelebi University with no 27 on 11032021 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 andor other dermatological diseases associated with the presence of Demodex mites receiving or having been receiving treatment for Demodex-associated dermatosis topical andor systemic using face wash gel andor 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 N95FFP2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None