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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2022-05-30

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.

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Detailed Description

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Conditions

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Irritation/Irritant ICD - Irritant Contact Dermatitis Antiseptic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

One forearm will be treated with the commercially available emollient while the other will be left untreated. Therefore the participants will not be blinded but the outcomes assessor and the principal investigator will be blinded to the treatment.

Disinterested third party will perform the randomization and treatment allocation, as well as keep the code breaks in case of medical emergency or adverse events of the interventions.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Emollient cream

Intervention Type OTHER

Commercially available emollient cream

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

Group Type ACTIVE_COMPARATOR

Emollient cream

Intervention Type OTHER

Commercially available emollient cream

No irritation and treatment

Intact skin on forearms Emollient cream treatment 3 times a day

Group Type ACTIVE_COMPARATOR

Emollient cream

Intervention Type OTHER

Commercially available emollient cream

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

No irritation and no treatment

Intact skin on forearms No emollient cream treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Emollient cream

Commercially available emollient cream

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes