The Effects of Repeated Exposure to Antiseptics During COVID-19 Pandemic on Skin Parameters
2022年3月11日 更新者：Dario Leskur、University of Split, School of Medicine
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.
調査の概要
研究の種類
介入
入学 (予想される)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Split、クロアチア、21000
- 募集
- University of Split School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Repated exposure to antiseptic and treatment
Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) Emollient cream treatment 3 times a day
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Commercially available emollient cream
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アクティブコンパレータ：Sham irritation and treatment
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
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Commercially available emollient cream
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アクティブコンパレータ：No irritation and treatment
Intact skin on forearms Emollient cream treatment 3 times a day
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Commercially available emollient cream
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介入なし：Repated exposure to antiseptic and no treatment
Repeated exposure of forearm skin to antiseptic (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
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|
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介入なし：Sham irritation and no treatment
Repeated exposure of forearm skin to deionized water (once daily for 2 hours under occlusion, during three weeks) No emollient cream treatment
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介入なし：No irritation and no treatment
Intact skin on forearms No emollient cream treatment
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Transepidermal water loss change
時間枠：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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Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
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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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Stratum corneum hydration change
時間枠：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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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
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Erythema change
時間枠：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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Mexameter will be used to assess erythema.
It is a relative measurement and uses arbitrary units (AU).
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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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Melanin content change
時間枠：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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Mexameter will be used to assess skin melanin content.
It is a relative measurement and uses arbitrary units (AU).
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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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Clinical score
時間枠：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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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.
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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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年3月7日
一次修了 (予想される)
2022年5月30日
研究の完了 (予想される)
2022年5月30日
試験登録日
最初に提出
2022年3月10日
QC基準を満たした最初の提出物
2022年3月10日
最初の投稿 (実際)
2022年3月11日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月28日
QC基準を満たした最後の更新が送信されました
2022年3月11日
最終確認日
2022年3月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2181-198-03-04-22-0009
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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