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

Irritation/Irritant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276102
• Other study ID #: 2181-198-03-04-22-0009
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: March 2022
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Antiseptic
• COVID-19
• Dermatitis
• Dermatitis, Contact
• Irritation/Irritant

Intervention

Other:
• Emollient cream
Commercially available emollient cream

Locations

Country	Name	City	State
Croatia	University of Split School of Medicine	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

References & Publications (5)

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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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