Clinical trial NCT05276102: The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters
Official title: The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritation/Irritant
ICD - Irritant Contact Dermatitis
Antiseptic
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transepidermal water loss change
timeFrame: 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
measure: Stratum corneum hydration change
timeFrame: 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
measure: Erythema change
timeFrame: 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
measure: Melanin content change
timeFrame: 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
measure: Clinical score
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.