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

Eczema Clinical Trial

— HET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01012453
• Other study ID #: SJ-126
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2009
• Last updated: November 12, 2009
• Start date: October 2009

Study information

• Verified date: November 2009
• Source: Roskilde County Hospital
• Contact: Kristina Sophie Ibler, MD, Ph.d-student
• Phone: +45-47322600
• Email: ksi[@]regionsjaelland.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Skin Disease
• Skin Diseases

Intervention

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.

Locations

Country	Name	City	State
Denmark	Holbaek Hospital	Holbaek
Denmark	Koege Hospital	Koege
Denmark	Dermatological Department, Roskilde County Hospital	Roskilde

Sponsors (3)

Lead Sponsor	Collaborator
Roskilde County Hospital	Region Zealand, The Danish Working Environment Authority

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.		6 months	No
Secondary	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		6 months	No