The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2022
CompletedFirst Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedMarch 28, 2022
March 1, 2022
3 months
March 10, 2022
March 11, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (6)
Repated exposure to antiseptic and treatment
ACTIVE COMPARATORRepeated 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 COMPARATORRepeated 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 COMPARATORIntact skin on forearms Emollient cream treatment 3 times a day
Repated exposure to antiseptic and no treatment
NO INTERVENTIONRepeated 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 INTERVENTIONRepeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
No irritation and no treatment
NO INTERVENTIONIntact skin on forearms No emollient cream treatment
Interventions
Commercially available emollient cream
Eligibility Criteria
You may qualify if:
- young, healthy volunteers who gave written informed consent
You may not qualify if:
- skin disease, skin damage on measurement sites
- non-adherence to the trial protocol
- pregnancy and lactation
- skin cancer
- immunosuppression
- exposure to artificial UV radiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Split School of Medicine
Split, 21000, Croatia
Related Publications (5)
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.
PMID: 34077565BACKGROUNDAkl 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.
PMID: 34077629BACKGROUNDElston 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.
PMID: 32171807BACKGROUNDPark 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.
PMID: 33217053BACKGROUNDTupker 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.
PMID: 9285167BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 11, 2022
Study Start
March 7, 2022
Primary Completion
May 30, 2022
Study Completion
May 30, 2022
Last Updated
March 28, 2022
Record last verified: 2022-03