Safety and tolerability of virucidal hand rubs: a randomized, double-blind, cross-over trial with healthy volunteers

BACKGROUND: The hands of the medical staff play an important role in transmission of pathogens in the health care environment. Hand hygiene is efficient, easy to perform and cost-effective. Safety, tolerability and acceptance of hand hygiene preparations play a major role in hand hygiene compliance, and apply, in particular, to formulations with high anti-viral activity. AIM: Clinical trial to evaluate the safety and tolerability of different virucidal hand rubs. METHODS: In a randomized, double-blind, four-period cross-over trial, healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of 4 days each with a washout period. The primary endpoint was skin barrier function measured by transepidermal water loss (TEWL) after application. RESULTS: Twenty-two subjects (seven male, 15 female; median age 25, range 21–54) were randomized and started at least one period. TEWL was 22.5; 95 %-confidence interval (CI): 19.6-25.4 after P1, 16.3; 13.5–19.1 after P2, 16.4; 13.4–19.3 after P3, and 24.0; 21.1–27.0 after R; p < 0.0001. The percentage of subjects experiencing at least one adverse event (AE) was 86 % with P1, 25 % with P2, 89 % with P3 and 56 % with R. The majority of AEs were skin reactions classified as of mild severity. No serious AEs were observed. CONCLUSIONS: Results were inconsistent. The number of AEs was higher than expected for all products. In summary, there is room for improvement both for hand rub development and the scientific approaches taken to practically and reproducibly evaluate hand rub safety and tolerability.