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

NCT01012453 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2009-11-13

No results posted yet for this study

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.

Conditions

  • Eczema
  • Dermatitis
  • Skin Disease

Interventions

BEHAVIORAL

A randomised clinical trial of the effect of classification and individual counselling

The trial to be conducted is a randomised single-blinded parallel study. It is divided in two stages, T = 0 and follow-up at T = 6 months. All included participants will have a clinical examination at the beginning and at follow-up in the trial. Half of the participants will be randomised to intervention, the other half to control. The participants in the intervention group will, after the first clinical examination, pass on directly to the intervention which includes an allergological examination (patch and prick testing). Three days later they will be examined by a physician who will interpret the patch test and give a thorough, individual guidance in skin protection and occupational safety. The clinical examination of all participants at follow-up will reveal the difference in outcomes in the intervention and the control group.

Sponsors & Collaborators

  • The Danish Working Environment Authority

    collaborator UNKNOWN

  • Region Zealand

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012453 on ClinicalTrials.gov