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

Zealand University Hospital

Status: Unknown

Conditions: Dermatitis; Skin Disease; Eczema

Treatments: Behavioral: A randomised clinical trial of the effect of classification and individual counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT01012453

SJ-126

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 1 patient group

Hand Eczema in health care workers

No Intervention group

Treatment:

Behavioral: A randomised clinical trial of the effect of classification and individual counselling