Clinical trial NCT04790799: Occupational Hand Eczema - Testing of a Prevention-concept
Official title: Occupational Hand Eczema - Establishment and Testing of a Prevention-concept With Focus on the Young Workforce
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Contact Dermatitis
Lead sponsor: National Allergy Research Center, Denmark
Sponsor class: OTHER
Collaborators: name: Arbejdsmiljøforskningsfonden
name: Bispebjerg Hospital
name: Frederiksberg University Hospital
name: National Research Centre for the Working Environment, Denmark
name: University of Osnabrueck
First posted: 2021-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)
timeFrame: Change between baseline and 3 months
measure: Change in severity of handeczema assessed by the photographic guide for severity of handeczema
timeFrame: Change between baseline and 3 months
measure: Change in severity of handeczema assessed by the photographic guide for severity of handeczema
timeFrame: Change between baseline and 6 months
measure: Change in severity of handeczema assessed by the photographic guide for severity of handeczema
timeFrame: Change between baseline and 9 months
measure: Change in severity of handeczema assessed by the photographic guide for severity of handeczema
timeFrame: Change between baseline and 12 months
measure: Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
timeFrame: Change between baseline and 3 months
measure: Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
timeFrame: Change between baseline and 6 months
measure: Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
timeFrame: Change between baseline and 9 months
measure: Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
timeFrame: Change between baseline and 12 months
measure: Amount of corticosteroids prescribed within the last year
timeFrame: Baseline
measure: Amount of corticosteroids prescribed within the last 3 months
timeFrame: 3 months
measure: Amount of corticosteroids prescribed within the last 3 months
timeFrame: 6 months
measure: Amount of corticosteroids prescribed within the last 3 months
timeFrame: 9 months
measure: Amount of corticosteroids prescribed within the last 3 months
timeFrame: 12 months
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: 3 months
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 9 months
measure: 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)
timeFrame: 12 months
measure: Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
timeFrame: Baseline
measure: Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
timeFrame: 3 months
measure: Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
timeFrame: 6 months
measure: Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
timeFrame: 9 months
measure: Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
timeFrame: 12 months
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: 3 months
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 9 months
measure: 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)
timeFrame: 12 months
measure: Number of participants with loss of job within the last year
timeFrame: Baseline
measure: Number of participants with loss of job within the last 3 months
timeFrame: Baseline
measure: Number of participants with loss of job within the last 3 months
timeFrame: 3 months
measure: Number of participants with loss of job within the last 3 months
timeFrame: 6 months
measure: Number of participants with loss of job within the last 3 months
timeFrame: 9 months
measure: Number of participants with loss of job within the last 3 months
timeFrame: 12 months
measure: Amount of sick leave within the last year
timeFrame: Baseline
measure: Amount of sick leave within the last 3 months
timeFrame: 3 months
measure: Amount of sick leave within the last 3 months
timeFrame: 6 months
measure: Amount of sick leave within the last 3 months
timeFrame: 9 months
measure: Amount of sick leave within the last 3 months
timeFrame: 12 months
measure: Number of participants with change of occupation due to occupational contact dermatitis within the last year
timeFrame: Baseline
measure: Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
timeFrame: 3 months
measure: Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
timeFrame: 6 months
measure: Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
timeFrame: 9 months
measure: Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Skin department
Study officials:
affiliation: National Allergy Research Center
name: Jeanne D Johansen, Professor
role: STUDY_DIRECTOR
References: