title: The use of a measure of acute irritation to predict the outcome of repeated usage of hand soap products.
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.
  
  
  OBJECTIVE
  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.affiliation: Department of Dermatology Clinical Trials Unit, Leeds General Infirmary, Leeds LS1 3EX, UK. tinawilliams@doctors.org.uk
authors.forename: C
authors.initials: C
authors.lastname: Williams
authors.forename: M
authors.initials: M
authors.lastname: Wilkinson
authors.forename: P
authors.initials: P
authors.lastname: McShane
authors.forename: D
authors.initials: D
authors.lastname: Pennington
authors.forename: C
authors.initials: C
authors.lastname: Fernandez
authors.forename: S
authors.initials: S
authors.lastname: Pierce
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017453:Dermatitis, Irritant / Q000175:diagnosis* / Q000209:etiology; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000175:diagnosis* / Q000209:etiology; D005260:Female; D006229:Hand Dermatoses / Q000139:chemically induced*; D006235:Hand Disinfection; D006801:Humans; D008297:Male; D008875:Middle Aged; D010328:Patch Tests; D011379:Prognosis; D012869:Skin Absorption / Q000187:drug effects; D012915:Soaps / Q000009:adverse effects*; D014870:Water Loss, Insensible / Q000187:drug effects; D055815:Young Adult
chemical_list: D012915:Soaps