The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 30, 2022

Interventions

  • Other: Emollient cream
    • Commercially available emollient cream

Arms, Groups and Cohorts

  • Active Comparator: 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
  • Active Comparator: 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
  • Active Comparator: No irritation and treatment
    • Intact skin on forearms Emollient cream treatment 3 times a day
  • No Intervention: 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
  • No Intervention: 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
  • No Intervention: No irritation and no treatment
    • Intact skin on forearms No emollient cream treatment

Clinical Trial Outcome Measures

Primary Measures

  • Transepidermal water loss change
    • Time Frame: 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
    • Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
  • Stratum corneum hydration change
    • Time Frame: 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
    • Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
  • Erythema change
    • Time Frame: 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).
  • Melanin content change
    • Time Frame: 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 skin melanin content. It is a relative measurement and uses arbitrary units (AU).
  • Clinical score
    • Time Frame: 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Split, School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dario Leskur, Assistant professor – University of Split, School of Medicine

References

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.

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.

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