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

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ClinicalTrials.gov Identifier: NCT01012453
Recruitment Status : Unknown
Verified November 2009 by Zealand University Hospital.
Recruitment status was:  Recruiting
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
Information provided by:

Study Description
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.


  • 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.

Condition or disease Intervention/treatment
Eczema Dermatitis Skin Disease Behavioral: A randomised clinical trial of the effect of classification and individual counselling

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2009
Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012453

Contact: Kristina Sophie Ibler, MD, Ph.d-student +45-47322600 ksi@regionsjaelland.dk
Contact: Tove Agner, MD, DM Science

Holbaek Hospital Not yet recruiting
Holbaek, Denmark, 4300
Principal Investigator: Kristina Sophie Ibler, MD, Ph.d-student         
Koege Hospital Not yet recruiting
Koege, Denmark, 4600
Principal Investigator: kristina Sophie Ibler, MD, Ph.d-student         
Dermatological Department, Roskilde County Hospital Recruiting
Roskilde, Denmark, 4000
Principal Investigator: Kristina Sophie Ibler, Md, Ph.d-student         
Sponsors and Collaborators
Zealand University Hospital
The Danish Working Environment Authority
Region Zealand
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristina Ibler MD, Ph.d student, Dermatological Department, Roskilde County Hospital
ClinicalTrials.gov Identifier: NCT01012453     History of Changes
Other Study ID Numbers: SJ-126
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

Keywords provided by Zealand University Hospital:
Hand eczema
Hand dermatitis
Occupational skin disease
skindisease in health care workers
occupational hand dermatitis
occupational hand eczema

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Eczematous