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

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritation/Irritant, ICD - Irritant Contact Dermatitis, Antiseptic

Intervention / Treatment
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* Other: Emollient cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each volar forearm of the participants will be divided in three sites, with each site randomly assigned to repeated exposure to antiseptic, repeated exposure to deionized water (sham irritation) or will be left intact. One forearm will be treated with the commercially available emollient three times a day while the other will be left untreated. Treated forearm (left or right) will be chosen according to randomization protocol (double randomization).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Repated exposure to antiseptic and treatment<br>Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day | Other: Emollient cream<br>* Commercially available emollient cream<br>|
| Active Comparator: Sham irritation and treatment<br>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 | Other: Emollient cream<br>* Commercially available emollient cream<br>|
| Active Comparator: No irritation and treatment<br>Intact skin on forearms Emollient cream treatment 3 times a day | Other: Emollient cream<br>* Commercially available emollient cream<br>|
| No Intervention: Repated exposure to antiseptic and no treatment<br>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<br>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<br>Intact skin on forearms No emollient cream treatment | |

What is the study measuring?
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Primary Outcome Measures

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