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

University of Split

Status

Unknown

Conditions

ICD - Irritant Contact Dermatitis

Antiseptic

Irritation/Irritant

Treatments

Other: Emollient cream

Study type

Interventional

Funder types

Other

Identifiers

NCT05276102

2181-198-03-04-22-0009

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 6 patient groups

Repated exposure to antiseptic and treatment

Active Comparator group

Description:

Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day

Treatment:

Other: Emollient cream

Sham irritation and treatment

Active Comparator group

Description:

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

Treatment:

Other: Emollient cream

No irritation and treatment

Active Comparator group

Description:

Intact skin on forearms Emollient cream treatment 3 times a day

Treatment:

Other: Emollient cream

Repated exposure to antiseptic and no treatment

No Intervention group

Description:

Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment