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Occupational Hand Eczema - Testing of a Prevention-concept

Not Applicable
Completed
Conditions
Occupational Contact Dermatitis
Interventions
Other: Treatment at the skin department at Gentofte Hospital
Registration Number
NCT04790799
Lead Sponsor
National Allergy Research Center, Denmark
Brief Summary

Randomised controlled trial examining the effect of decreased waiting time for the first doctors' appointment, patient education, glove counselling and counselling at departments of social or occupational medicine on severity of hand eczema, quality of life, use of corticosteroids, and jobsituation 3-12 months after intervention in patients with suspected occupational contact dermatitis of the hands.

Detailed Description

Patients with suspected occupational hand eczema are recruited to the study on basis of their referral from general practitioner to dermatologist. Patients are randomised to either control or intervention group. The control group is treated and followed-up by the dermatologist they have been referred to, while the intervention group is treated and followed-up at Gentofte Hospital skin department with a maximum waiting time of 3 weeks. At the skin department at Gentofte Hospital, the patients in the intervention group receive patient education in prevention and treatment of hand eczema, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. Patients in both the control and intervention group are asked to fill out a questionnaire at 3, 6, 9 and 12 months after inclusion in the study. The questionnaire contains questions about quality of life, severity of hand exzema, jobsituation, use of healthcare service and use of medicine. Furthermore, prescriptions of medicine are registered in both control and intervention group at 3, 6, 9 and 12 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Referred from a general practitioner to a dermatologist
  • Hand eczema within the last 3 months
  • Suspicion that the hand eczema is work-related (either patient and/or doctors suspicion)
Exclusion Criteria
  • Does not read and write danish
  • Severe psychiatric illness
  • Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupTreatment at the skin department at Gentofte HospitalTreatment in a hospital setting at Gentofte Hospital skin department with patient education, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema.
Primary Outcome Measures
NameTimeMethod
Change in severity of handeczema assessed by the photographic guide for severity of handeczemaChange between baseline and 12 months

Self-assessed photographic guide

Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)Change between baseline and 3 months

The hand eczema severity index (HECSI)

Number of participants with loss of job within the last yearBaseline

Self-repported loss of job wihtin the last year

Amount of corticosteroids prescribed within the last 3 months12 months

Amount of corticosteroids prescribed within the last 3 months

Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life)12 months

Skindex-29

Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)Change between baseline and 12 months

Visual analog Score for severity of handeczema

Amount of corticosteroids prescribed within the last yearBaseline

Amount of corticosteroids prescribed wihtin the last year

Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)12 months

"European Quality of Life - 5 Dimensions" (EQ-5D)

Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life)12 months

Dermatology life quality index (DLQI)

Number of participants with loss of job within the last 3 months12 months

Self-repported loss of job within the last 3 months

Amount of sick leave within the last 3 months12 months

Self-repported amount of sick leave within the last 3 months

Number of participants with change of occupation due to occupational contact dermatitis within the last yearBaseline

Change of occupation due to occupational contact dermatitis within the last year

Amount of sick leave within the last yearBaseline

Self-repported amount of sick leave within the last year

Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months12 months

Change of occupation due to occupational contact dermatitis within the last 3 months

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Gentofte Hospital, Skin department

🇩🇰

Hellerup, Denmark

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