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The use of a measure of acute irritation to predict the outcome of repeated usage of hand soap products.
Br J Dermatol. 2011 Jun; 164(6):1311-5.BJ

Abstract

BACKGROUND

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.

OBJECTIVES

To assess whether a measure of acute irritation by hand soaps could predict the effects of repeated usage over a 2-week period.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

Department of Dermatology Clinical Trials Unit, Leeds General Infirmary, Leeds LS1 3EX, UK. tinawilliams@doctors.org.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21332456

Citation

Williams, C, et al. "The Use of a Measure of Acute Irritation to Predict the Outcome of Repeated Usage of Hand Soap Products." The British Journal of Dermatology, vol. 164, no. 6, 2011, pp. 1311-5.
Williams C, Wilkinson M, McShane P, et al. The use of a measure of acute irritation to predict the outcome of repeated usage of hand soap products. Br J Dermatol. 2011;164(6):1311-5.
Williams, C., Wilkinson, M., McShane, P., Pennington, D., Fernandez, C., & Pierce, S. (2011). The use of a measure of acute irritation to predict the outcome of repeated usage of hand soap products. The British Journal of Dermatology, 164(6), 1311-5. https://doi.org/10.1111/j.1365-2133.2011.10246.x
Williams C, et al. The Use of a Measure of Acute Irritation to Predict the Outcome of Repeated Usage of Hand Soap Products. Br J Dermatol. 2011;164(6):1311-5. PubMed PMID: 21332456.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The use of a measure of acute irritation to predict the outcome of repeated usage of hand soap products. AU - Williams,C, AU - Wilkinson,M, AU - McShane,P, AU - Pennington,D, AU - Fernandez,C, AU - Pierce,S, PY - 2011/2/22/entrez PY - 2011/2/22/pubmed PY - 2012/1/21/medline SP - 1311 EP - 5 JF - The British journal of dermatology JO - Br J Dermatol VL - 164 IS - 6 N2 - BACKGROUND: 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. OBJECTIVES: To assess whether a measure of acute irritation by hand soaps could predict the effects of repeated usage over a 2-week period. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/21332456/The_use_of_a_measure_of_acute_irritation_to_predict_the_outcome_of_repeated_usage_of_hand_soap_products_ L2 - https://doi.org/10.1111/j.1365-2133.2011.10246.x DB - PRIME DP - Unbound Medicine ER -