Antiseptic, ICD - Irritant Contact Dermatitis, Irritation/Irritant
Conditions
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.
Interventions
OTHEREmollient cream
Commercially available emollient cream
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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. |
Countries
Croatia
Outcome results
None listed