A 24-week Single-blind Trial of Prevention of Hand Eczema in Cleaners

Hand Eczema in Cleaners: a Randomized Clinical Trial of Picture-based Prevention Compared to Treatment as Usual Among Professional Hospital Cleaners

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05763914

Acronym

HEIC

Enrollment

234

Registered

2023-03-10

Start date

2022-11-14

Completion date

2023-06-24

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Eczema

Keywords

Prevention, Occupational, Picture, Cleaning

Brief summary

This study aims to investigate the effectiveness of picture-based prevention education among professional hospital cleaners in relation to hand eczema. This is a single-blinded randomized clinical trial including hospital cleaners at three different hospitals.

Interventions

BEHAVIORALChange in the incidence of hand eczema

Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.

BEHAVIORALChange in severity of hand eczema

Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.

BEHAVIORALChange in the number of self-reported days with absence from work due to having hand eczema

Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.

BEHAVIORALChange in the number of participants being forced to change their job due to having hand eczema

Self-reported change of job due to having hand eczema. Change between baseline and 6 months.

BEHAVIORALChange in The Quality Of Life in in relation to hand eczema

Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.

BEHAVIORALChange in the level of knowledge regarding skin care and protection.

Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Intervention model description

A cluster-randomized clinical trial, including three different hospitals. At each hospital, 78 cleaners will be included.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Professional hospital cleaners ≥ 18 years old * Sufficient Danish skills * Written informed consent

Exclusion criteria

* Insufficient Danish skills * Pregnancy * Other skin diseases on the hands * Receiving Immunomodulatory therapies

Design outcomes

Primary

Measure	Time frame	Description
Incidence rate of hand eczema	Change between baseline and 6 months	Measured by a self-reported questionnaire
Hand Eczema Severity Index (HECSI)	Change between baseline and 6 months	Objective assessment of disease severity, measured by HECSI-score: 0-360 points (0 best, 360) worst)

Secondary

Measure	Time frame	Description
Rate of absence from work due to having hand eczema	Change between baseline and 6 months	Measured by a self-reported questionnaire
Rate of participants being forced to change their job due to having hand eczema (questionnaire-based).	Change between baseline and 6 months	Measured by a self-reported questionnaire
The Quality Of Life in Hand Eczema Questionnaire (QqlHEQ)	Change between baseline and 6 months	Subjective assessment of quality of life using QqlHEQ which contains 30 items; generally, all items are scored 0-4 (only three items differ in their scoring structure).
Rate of knowledge regarding skin care and protection.	Change between baseline and 6 months	Measured by a self-reported questionnaire

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026