Clinical trial NCT01012453: A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema
Official title: Hand Eczema Trial: A Randomised Clinical Trial of the Effect of Classification and Individual Counselling Among Health Care Workers With Hand Eczema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eczema
Dermatitis
Skin Disease
Keywords: Hand eczema
Hand dermatitis
Occupational skin disease
skindisease in health care workers
occupational hand dermatitis
occupational hand eczema
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Working Environment Authority
name: Region Zealand
First posted: 2009-11-13
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives and perspective:

1. To estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . To investigate the knowledge of skin protection among health care workers.
2. To classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema
3. To evaluate the effect of a combination of classification of hand eczema and individual work-related counseling in skin protective behavior.

The overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers.

Hypotheses:

* Irritant contact dermatitis is more common than allergic contact dermatitis.
* The combination of precise classification (subtyping of HE) and individual counseling will have a positive impact on the prognosis of hand eczema.
* The positive impact on the prognosis of hand eczema will have a positive impact on quality of life (QoL).
* The knowledge of protective behavior will increase.
* Education in a skin care program will have a positive impact on skin protective behavior.


Eligibility criteria: Inclusion Criteria:

* Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
* Informed written consent must be present in order to participate.

Exclusion Criteria:

* Pregnancy
* Systemic use of immunosuppressive drugs
* Systemic use of retinoids
* Active psoriatic lesions on the hands
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
* Lack of informed written consent

Primary outcomes:
measure: Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
timeFrame: 6 months
Secondary outcomes:
measure: Secondary outcomes: -Subjective assessment of disease severity (HE) -Number of eruptions through the past three months -Knowledge of skin protection -Skinprotective behaviour -Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Holbaek Hospital
city: Koege
country: Denmark
facility: Koege Hospital
city: Roskilde
country: Denmark
facility: Dermatological Department, Roskilde County Hospital
Study officials:
References:
citation: Ibler KS, Jemec GB, Diepgen TL, Gluud C, Lindschou Hansen J, Winkel P, Thomsen SF, Agner T. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ. 2012 Dec 12;345:e7822. doi: 10.1136/bmj.e7822.
citation: Ibler KS, Agner T, Hansen JL, Gluud C. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema. BMC Dermatol. 2010 Aug 31;10:8. doi: 10.1186/1471-5945-10-8.