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Assessment of tolerability and acceptability of an alcohol-based hand rub according to a WHO protocol and using
Patryk Tarka1, Katarzyna Gutkowska1, Aneta Nitsch-Osuch1
1Department of Social Medicine and Public Health, Medical University of Warsaw, ul Oczki 3, 02-007 Warsaw, Poland.
Background:
The 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).
Methods:
Among 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.
Results:
We 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).
Conclusions:
The 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.
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