Assessment of tolerability and acceptability of an alcohol-based hand rub according to a WHO protocol and using apparatus tests

Abstract

BackgroundThe effectiveness of alcohol-based hand rubs (ABHRs) depends substantially on their acceptability and tolerability. In this study, we assessed the acceptability and tolerability of a new ABHR (product EU 100.2018.02).MethodsAmong physicians, nurses, and cosmetologists who used the ABHR for 30 days, we assessed the product’s acceptability and tolerability according to a WHO protocol. Additionally, we used instrumental skin tests. Participants assessed the product’s color, smell, texture, irritation, drying effect, ease of use, speed of drying, and application, and they gave an overall evaluation. Moreover, they rated the tolerability, i.e. their skin condition, on the following dimensions: intactness, moisture content, sensation, and integrity of the skin. The tolerability was also assessed by an observer as follows: redness, scaliness, fissures, and overall score for the skin condition. Instrumental skin tests included transepidermal water loss, skin hydration, sebum secretion, and percentage of skin affected by discolorations. All assessments were made at baseline (visit 1), and 3–5 days (visit 2) and 30 days (visit 3) later.ResultsWe enrolled 126 participants (110 [87%] women) with a mean age of 34.3 ± 11.65 years. Sixty-five participants (52%) were healthcare professionals (physicians, nurses), and 61 (48%) were cosmetologists. During visit 2 and visit 3, about 90% of participants gave responses complying with the WHO’s benchmark for acceptability and tolerability. Similarly, the ABHR met the WHO criteria for observer-assessed tolerability: on all visits, in more than 95% of participants, the observer gave scores complying with the WHO benchmark. Transepidermal water loss decreased from baseline to visit 3 (p < 0.001), whereas skin hydration, sebum secretion, and the percentage of skin affected by discolorations did not change significantly during the study (p ≥ 130).ConclusionsThe EU 100.2018.02 had both high acceptability and tolerability, meeting the WHO criteria. The WHO protocol proved useful in the analysis of acceptability and tolerability of ABHRs.

Alcohol-containing Hand Rubs: A Survey on Beliefs and Self-reported Practices of Muslim Nurses

“…Amongst our study population, about one third of nurses were concerned about adverse skin irritation side effects of alcohol-based hand rubs. This finding was in line with many other studies in which a commonly reported side effect of ABHRs was skin dryness and irritation (Assefa et al 2021;Kampf and Löffler 2007;Sharma et al 2015;Takra, Gutkowska, and Nitsch-Osuch 2019). Skin irritation and contact dermatitis with ABHRs were specially reported in people with an aldehyde dehydrogenase deficiency (Lachenmeier 2008).…”

Hand sanitisers amid CoViD-19: A critical review of alcohol-based products on the market and formulation approaches to respond to increasing demand

“…However, ethanol has superior viricidal activity than propanols against non-enveloped viruses (Kampf, 2018a). Also, skin tolerance is better with ethanol compared to n-propanol or isopropanol (Cartner et al, 2017;Houben et al, 2006), thus ethanol is often the alcohol of choice in the ABHR preparations (Suchomel and Rotter, 2011;Tarka et al, 2019).…”

Determination of alcohols in hand sanitisers: Are off-the-shelf hand sanitisers what they claim to be?

“…Ethanol was the preferred alcohol over propanols for ABHR formulations because of its superior virucidal activity and its skin tolerance. 17,18 A vast majority of the products analysed did not contain alcohols in the compositions recommended by the WHO (80±5 v/v% for ethanol and 70±5 v/v% for isopropanol). 9 Most also did not contain the required 70% ethanol recommended by the US Centers for Disease Control and Prevention (CDC).…”