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

• ClinicalTrials.gov Identifier: NCT01012453
• Recruitment Status: Unknown
• First Posted: November 13, 2009
• Last Update Posted: November 13, 2009
• Sponsor: Zealand University Hospital
• Collaborators: The Danish Working Environment Authority; Region Zealand
• Information provided by: Zealand University Hospital

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.

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 or disease	Intervention/treatment	Phase
Eczema; Dermatitis; Skin Disease	Behavioral: A randomised clinical trial of the effect of classification and individual counselling	Not Applicable

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
• Actual Primary Completion Date: October 2009

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

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

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

Zealand University Hospital

The Danish Working Environment Authority

Region Zealand

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ibler KS, Jemec GB, Diepgen TL, Gluud C, Lindschou Hansen J, Winkel P, Thomsen SF, Agner T. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ. 2012 Dec 12;345:e7822. doi: 10.1136/bmj.e7822.

Ibler KS, Agner T, Hansen JL, Gluud C. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema. BMC Dermatol. 2010 Aug 31;10:8. doi: 10.1186/1471-5945-10-8.

• Responsible Party: Kristina Ibler MD, Ph.d student, Dermatological Department, Roskilde County Hospital
• ClinicalTrials.gov Identifier: NCT01012453
• Other Study ID Numbers: SJ-126
• First Posted: November 13, 2009
• 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:

Dermatitis; Eczema; Skin Diseases; Skin Diseases, Eczematous