Trial record 2 of 47 for:    Open Studies | "Eczema"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Roskilde County Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Danish Working Environment Authority
Region Zealand
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT01012453
First received: November 12, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012453

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

Locations
Denmark
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
Roskilde County Hospital
The Danish Working Environment Authority
Region Zealand
  More Information

No publications provided by Roskilde County Hospital

Additional 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
Study First Received: November 12, 2009
Last Updated: November 12, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Dermatitis
Skin Diseases
Eczema
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on September 16, 2014