The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters
11. mars 2022 oppdatert av: Dario Leskur, University of Split, School of Medicine
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 the skin of the hands due to the use of antiseptics have been observed in a number of studies, however, part of the study was based solely on subjects' self-assessment or clinical assessment of researchers, and only a small part on objective measurements of skin parameters. Also, the impact of prolonged use of antiseptics and the impact of measures to prevent and protect against irritation such as topical application of emollient preparations have not been investigated.
The impact of repeated use of antiseptics in the repeated exposure model on the forearms will be investigated. This model is a modification of the existing model of irritative dermatitis induced by sodium lauryl sulfate where the original irritant was replaced by an antiseptic solution.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Split, Kroatia, 21000
- Rekruttering
- University of Split School of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- young, healthy volunteers who gave written informed consent
Exclusion Criteria:
- 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
- pregnancy and lactation
- skin cancer
- immunosuppression
- exposure to artificial UV radiation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Repated exposure to antiseptic and treatment
Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day
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Commercially available emollient cream
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Aktiv komparator: Sham irritation and treatment
Repeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day
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Commercially available emollient cream
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Aktiv komparator: No irritation and treatment
Intact skin on forearms Emollient cream treatment 3 times a day
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Commercially available emollient cream
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Ingen inngripen: Repated exposure to antiseptic and no treatment
Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
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Ingen inngripen: Sham irritation and no treatment
Repeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
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Ingen inngripen: No irritation and no treatment
Intact skin on forearms No emollient cream treatment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Transepidermal water loss change
Tidsramme: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
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Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Stratum corneum hydration change
Tidsramme: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Corneometer will be used to estimate skin dryness.
It is a relative measurement and uses arbitrary units (AU).
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Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
|
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Erythema change
Tidsramme: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
|
Mexameter will be used to assess erythema.
It is a relative measurement and uses arbitrary units (AU).
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Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Melanin content change
Tidsramme: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Mexameter will be used to assess skin melanin content.
It is a relative measurement and uses arbitrary units (AU).
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Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Clinical score
Tidsramme: Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Skin response to irritation and treatment will be assessed using a five-point scale (0, 1/2, 1, 2 and 3) to describe changes in skin erythema, roughness, scaling, oedema, and fissures, with higher score signifying a worse outcome.
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Baseline value measurements on the first day of trial, during the three weeks the skin is repeatedly exposed to antiseptic as well recovery during the following two weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Tupker RA, Willis C, Berardesca E, Lee CH, Fartasch M, Agner T, Serup J. Guidelines on sodium lauryl sulfate (SLS) exposure tests. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1997 Aug;37(2):53-69. doi: 10.1111/j.1600-0536.1997.tb00041.x.
- 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.
- Akl 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.
- Elston 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.
- Park 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. mars 2022
Primær fullføring (Forventet)
30. mai 2022
Studiet fullført (Forventet)
30. mai 2022
Datoer for studieregistrering
Først innsendt
10. mars 2022
Først innsendt som oppfylte QC-kriteriene
10. mars 2022
Først lagt ut (Faktiske)
11. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hudsykdommer
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungebetennelse, viral
- Lungebetennelse
- Lungesykdommer
- Hudsykdommer, eksem
- Covid-19
- Dermatitt
- Dermatitt, kontakt
- Dermatitt, irriterende
- Dermatologiske midler
- Bløtgjørende midler
Andre studie-ID-numre
- 2181-198-03-04-22-0009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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