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

November 12, 2009
November 12, 2009
October 2009
October 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Eczema
  • Dermatitis
  • Skin Disease
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.
No Intervention: Hand Eczema in health care workers
Intervention: Behavioral: A randomised clinical trial of the effect of classification and individual counselling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
October 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Kristina Sophie Ibler, MD, Ph.d-student +45-47322600 ksi@regionsjaelland.dk
Contact: Tove Agner, MD, DM Science
Denmark
 
NCT01012453
SJ-126
No
Kristina Ibler MD, Ph.d student, Dermatological Department, Roskilde County Hospital
Roskilde County Hospital
  • The Danish Working Environment Authority
  • Region Zealand
Not Provided
Roskilde County Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP