Evaluating the tolerability and acceptability of an alcohol-based hand rub – real-life experience with the WHO protocol

Study setting and protocol

The study was conducted between May and July 2013 at the Division of Infectious Diseases
and Infection Control, University Hospital Zurich, Zurich, Switzerland. The methodology
was based on the published WHO protocol “Method 1 for Evaluation of tolerability and
acceptability of alcohol-based hand rub in use or planned to be introduced” 13]. Three minor modifications were made to the WHO protocol: skin type was assessed
with by observer according to Fitzpatrick skin sensitivity type (and not self-assessed
by participant), participants were allowed to continue their usual hand care products
during the whole study period, and a question on product accessibility was added.

Study population

The study was carried out in healthy adults of ?18 years of age. Participants were
not allowed to have significant skin or systemic disease or any intolerance to any
component of the test preparation. The observer was a medical doctor (AW) trained
by an expert who participated in establishing and validating the WHO protocol (MNC,
see acknowledgements).

Study design and endpoints

Each participant received the test product in a 100 ml personal dispenser. Three visits
took place: a baseline visit 1 at day 0, visit 2 between day 3 and 5 of product use,
visit 3 at the study end after one month of product use.

The quantity of product used was measured at visit 2 and 3 to assure a minimal mean
daily use of at least 30 ml of the test product.

The primary endpoint was the observer assessment of skin condition of the participants’
hands using validated scales with higher scores meaning worse conditions including
the items redness (score, 0–4), scaliness (0–3), fissures (0–3), and visual scoring of skin (1–5). This primary endpoint was evaluated at all three study visits 16].

Secondary endpoints were participant assessment of skin tolerability on a rating scale
1–7 including the items appearance, intactness, moisture content, and sensation (all, ‘abnormal’-‘normal’) and overall skin integrity (‘very altered’-‘perfect’) and product acceptability including the items color (‘unpleasant’-‘pleasant’), smell (‘unpleasant’-‘pleasant’), texture (‘very sticky’-‘not sticky at all’), irritation (‘very irritating’-‘not irritating’), drying effect (‘very much’-‘not at all’), ease of use (‘very difficult’-‘very easy’), speed of drying (‘very slow’-‘very fast’), application (‘unpleasant’-‘pleasant’), overall evaluation (‘dissatisfied’-‘very satisfied’). Participant evaluations were carried out at visit
2 and visit 3.

WHO hand rub quality benchmarks

WHO defined benchmark criteria for an acceptable quality for ABHR to help purchasing
decision-making. Objective scores for skin condition must score lower than 2 in???75%
of assessments. Participant evaluation of skin condition must score above 4 in???75%
of cases. Participant acceptance must score for color and smell above 4 in???50% of the answers and above 4 in???75% of ratings for the other items
in this dimension 13].

Statistical analysis

The results were interpreted descriptively according to the WHO ‘Method 1’ 13].

Evaluation of WHO protocol feasibility and applicability

To evaluate the practicability of the WHO protocol, observer and participant time
was registered.

The study was formally accepted by the Ethics board of the Canton of Zurich (ID number
KEK-ZH-Nr. 2012–0444).