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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05276102
Other study ID # 2181-198-03-04-22-0009
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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