A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema

Not Applicable

• Conditions: Eczema; Dermatitis; Skin Disease
• Interventions: Behavioral: A randomised clinical trial of the effect of classification and individual counselling

• Registration Number: NCT01012453
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-10
• Status Verified: 2009-11
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-12
• Last Update Submitted: 2009-11-12
• Study First Posted: 2009-11-13
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand Eczema in health care workers	A randomised clinical trial of the effect of classification and individual counselling	-

Primary Outcome Measures

Name	Time	Method
Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.	6 months

Secondary Outcome Measures

Name	Time	Method
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	6 months

Trial Locations

Locations (3)

Dermatological Department, Roskilde County Hospital; 🇩🇰 Roskilde, Denmark

Koege Hospital; 🇩🇰 Koege, Denmark

Holbaek Hospital; 🇩🇰 Holbaek, Denmark