Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repated exposure to antiseptic and treatment | Active Comparator | Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day |
|
| Sham irritation and treatment | Active Comparator | 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 |
|
| No irritation and treatment | Active Comparator | Intact skin on forearms Emollient cream treatment 3 times a day |
|
| Repated exposure to antiseptic and no treatment | No Intervention | Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment | |
| Sham irritation and no treatment | No Intervention | Repeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment | |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emollient cream | Other | Commercially available emollient cream |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Split School of Medicine | Recruiting | Split | 21000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34077565 | Background | Montero-Vilchez T, Cuenca-Barrales C, Martinez-Lopez A, Molina-Leyva A, Arias-Santiago S. Skin adverse events related to personal protective equipment: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2021 Oct;35(10):1994-2006. doi: 10.1111/jdv.17436. Epub 2021 Jun 29. | |
| 34077629 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
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).
Not provided
Not provided
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.
| No irritation and no treatment |
| No Intervention |
Intact skin on forearms No emollient cream treatment |
| Akl J, El-Kehdy J, Salloum A, Benedetto A, Karam P. Skin disorders associated with the COVID-19 pandemic: A review. J Cosmet Dermatol. 2021 Oct;20(10):3105-3115. doi: 10.1111/jocd.14266. Epub 2021 Jul 1. |
| 32171807 | Background | Elston DM. Occupational skin disease among health care workers during the coronavirus (COVID-19) epidemic. J Am Acad Dermatol. 2020 May;82(5):1085-1086. doi: 10.1016/j.jaad.2020.03.012. Epub 2020 Mar 18. No abstract available. |
| 33217053 | Background | Park SR, Han J, Yeon YM, Kang NY, Kim E. Effect of face mask on skin characteristics changes during the COVID-19 pandemic. Skin Res Technol. 2021 Jul;27(4):554-559. doi: 10.1111/srt.12983. Epub 2020 Nov 20. |
| 9285167 | Background | Tupker RA, Willis C, Berardesca E, Lee CH, Fartasch M, Agner T, Serup J. Guidelines on sodium lauryl sulfate (SLS) exposure tests. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1997 Aug;37(2):53-69. doi: 10.1111/j.1600-0536.1997.tb00041.x. |
| D017443 |
| Skin Diseases, Eczematous |