Department of Dermatology Clinical Trials Unit, Leeds General Infirmary, Leeds LS1 3EX, UK.
Br J Dermatol. 2011 Jun;164(6):1311-5. doi: 10.1111/j.1365-2133.2011.10246.x.
Healthcare-associated infection is an important worldwide problem that could be reduced by better hand hygiene practice. However, an increasing number of healthcare workers are experiencing irritant contact dermatitis of the hands as a result of repeated hand washing. This may lead to a reduced level of compliance with regard to hand hygiene.
To assess whether a measure of acute irritation by hand soaps could predict the effects of repeated usage over a 2-week period.
In a double-blind, randomized comparison study, the comparative irritation potential of four different hand soaps was assessed over a 24-h treatment period. The effect of repeated hand washing with the hand soap products over a 2-week period in healthy adult volunteers on skin barrier function was then determined by assessment of transepidermal water loss (TEWL), epidermal hydration and a visual assessment using the Hand Eczema Severity Index (HECSI) at days 0, 7 and 14.
A total of 121 subjects from the 123 recruited completed phase 1 of the study. All four products were seen to be significantly different from each other in terms of the irritant reaction observed and all products resulted in a significantly higher irritation compared with the no-treatment control. Seventy-nine of the initial 121 subjects were then enrolled into the repeated usage study. A statistically significant worsening of the clinical condition of the skin as measured by HECSI was seen from baseline to day 14 in those subjects repeatedly washing their hands with two of the four soap products (products C and D) with P-values of 0·02 and 0·01, respectively. Subclinical assessment of the skin barrier function by measuring epidermal hydration was significantly increased from baseline to day 7 after repeated hand washing with products A, B and D but overall no significant change was seen in all four products tested by day 14. A statistically significant increase in TEWL at day 14 was seen for product A (P = 0·02) indicating a worsening of skin barrier function. This effect was also seen initially for product D at day 7 although this was then lost at day 14. Further regression analysis was then performed to see if the acute irritant test data for each product correlated with the skin barrier data from the repeated usage component of the study. This showed that the results of acute irritant testing of the individual products did not predict the results of chronic use of hand soaps.
The results from phase 2 of our study confirm the work of previous studies that show that regular exposure to irritants in daily life leads to stratum corneum damage and impairment of the skin barrier. Although significant differences were seen between the products in phase 1 of the study, regression analysis showed that the results of patch testing of the individual products did not predict the results of chronic use of hand soaps. When designing a study to assess the effects of cumulative use of a product on the skin, the study should mirror the use conditions of the product as closely as possible.
医疗保健相关感染是一个全球性的重要问题，可以通过更好的手部卫生实践来减少。然而，由于反复洗手，越来越多的医护人员手部出现刺激性接触性皮炎。这可能导致手部卫生的依从性降低。
评估手部肥皂的急性刺激测量是否可以预测重复使用 2 周后的效果。
在一项双盲、随机对照研究中，评估了四种不同肥皂的比较刺激潜力，在 24 小时治疗期间。然后，通过评估经皮水分流失（TEWL）、表皮水分和使用手部湿疹严重指数（HECSI）进行的视觉评估，确定健康成年志愿者在两周内用肥皂产品反复洗手对皮肤屏障功能的影响。在第 0、7 和 14 天。
从最初招募的 121 名受试者中，共有 121 名受试者完成了研究的第 1 阶段。所有四种产品在观察到的刺激性反应方面都明显不同于彼此，所有产品的刺激性都明显高于无治疗对照组。然后，从最初的 121 名受试者中招募了 79 名进入重复使用研究。在那些用四种肥皂产品中的两种（产品 C 和 D）反复洗手的受试者中，皮肤状况的临床评估（通过 HECSI 测量）从基线到第 14 天明显恶化，P 值分别为 0.02 和 0.01。通过测量表皮水分对皮肤屏障功能进行亚临床评估，从第 7 天到第 7 天，产品 A、B 和 D 反复洗手后，表皮水分显著增加，但到第 14 天，所有四种产品均未见明显变化。在第 14 天，产品 A 的 TEWL 显著增加（P = 0.02），表明皮肤屏障功能恶化。这种效应在第 7 天也最初出现在产品 D 中，尽管随后在第 14 天消失。然后进行了进一步的回归分析，以观察每个产品的急性刺激测试数据是否与研究重复使用部分的皮肤屏障数据相关。结果表明，各产品的急性刺激试验结果并不能预测肥皂的慢性使用结果。
我们研究第二阶段的结果证实了之前的研究工作，表明日常生活中经常接触刺激物会导致角质层损伤和皮肤屏障受损。尽管在研究的第 1 阶段观察到产品之间存在显著差异，但回归分析表明，对个别产品的斑贴试验结果并不能预测肥皂的慢性使用结果。在设计评估产品累积使用对皮肤影响的研究时，研究应尽可能紧密地反映产品的使用条件。
