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

Not Applicable

• Conditions: Irritation/Irritant; ICD - Irritant Contact Dermatitis; Antiseptic
• Interventions: Other: Emollient cream

• Registration Number: NCT05276102
• Lead Sponsor: University of Split, School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-07
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-11
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-28
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham irritation and treatment	Emollient cream	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
Repated exposure to antiseptic and treatment	Emollient cream	Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day
No irritation and treatment	Emollient cream	Intact skin on forearms Emollient cream treatment 3 times a day

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss change	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).
Erythema change	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	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	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.
Stratum corneum hydration change	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).

Trial Locations

Locations (1)

University of Split School of Medicine; 🇭🇷 Split, Croatia