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

November 12, 2009 updated by: Zealand University Hospital

Hand Eczema Trial: A Randomised Clinical Trial of the Effect of Classification and Individual Counselling Among Health Care Workers With Hand Eczema

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tove Agner, MD, DM Science

Study Locations

  • Denmark
      • Holbaek, Denmark, 4300
        • Not yet recruiting
        • Holbaek Hospital
        • Principal Investigator:
          • Kristina Sophie Ibler, Md, Ph.d-student
      • Koege, Denmark, 4600
        • Not yet recruiting
        • Koege Hospital
        • Principal Investigator:
          • Kristina Sophie Ibler, Md, Ph.d-student
      • Roskilde, Denmark, 4000
        • Recruiting
        • Dermatological Department, Roskilde County Hospital
        • Principal Investigator:
          • Kristina Sophie Ibler, Md, Ph.d-student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Hand Eczema in health care workers
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Region Zealand
The Danish Working Environment Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 12, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

November 13, 2009

Last Update Submitted That Met QC Criteria

November 12, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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