Occupational Hand Eczema - Testing of a Prevention-concept

Occupational Hand Eczema - Establishment and Testing of a Prevention-concept With Focus on the Young Workforce

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.

Study Overview

• Status: Completed
• Conditions: Occupational Contact Dermatitis
• Intervention / Treatment: Other: Treatment at the skin department at Gentofte Hospital

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jojo B Dietz, M.D.; Phone Number: +45 38 67 37 55; Email: jojo.biel-nielsen.dietz@regionh.dk

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital, Skin department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Treatment 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.	Other: Treatment at the skin department at Gentofte Hospital; Treatment in a hospital setting at Gentofte Hospital skin department
No Intervention: Control group; Treatment as usual (at a dermatologist office).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)	The hand eczema severity index (HECSI)	Change between baseline and 3 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 3 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 6 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 9 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 12 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)	Visual analog Score for severity of handeczema	Change between baseline and 3 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)	Visual analog Score for severity of handeczema	Change between baseline and 6 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)	Visual analog Score for severity of handeczema	Change between baseline and 9 months
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)	Visual analog Score for severity of handeczema	Change between baseline and 12 months
Amount of corticosteroids prescribed within the last year	Amount of corticosteroids prescribed wihtin the last year	Baseline
Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	3 months
Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	6 months
Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	9 months
Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	12 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)	Skindex-29	Baseline
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)	Skindex-29	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)	Skindex-29	6 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)	Skindex-29	9 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)	Skindex-29	12 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)	"European Quality of Life - 5 Dimensions" (EQ-5D)	Baseline
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)	"European Quality of Life - 5 Dimensions" (EQ-5D)	3 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)	"European Quality of Life - 5 Dimensions" (EQ-5D)	6 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)	"European Quality of Life - 5 Dimensions" (EQ-5D)	9 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)	"European Quality of Life - 5 Dimensions" (EQ-5D)	12 months
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)	Dermatology life quality index (DLQI)	Baseline
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)	Dermatology life quality index (DLQI)	3 months
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)	Dermatology life quality index (DLQI)	6 months
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)	Dermatology life quality index (DLQI)	9 months
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)	Dermatology life quality index (DLQI)	12 months
Number of participants with loss of job within the last year	Self-repported loss of job wihtin the last year	Baseline
Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	Baseline
Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	3 months
Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	6 months
Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	9 months
Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	12 months
Amount of sick leave within the last year	Self-repported amount of sick leave within the last year	Baseline
Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	3 months
Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	6 months
Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	9 months
Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	12 months
Number of participants with change of occupation due to occupational contact dermatitis within the last year	Change of occupation due to occupational contact dermatitis within the last year	Baseline
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months	Change of occupation due to occupational contact dermatitis within the last 3 months	3 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months	Change of occupation due to occupational contact dermatitis within the last 3 months	6 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months	Change of occupation due to occupational contact dermatitis within the last 3 months	9 months
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months	Change of occupation due to occupational contact dermatitis within the last 3 months	12 months

Collaborators and Investigators

• Sponsor: National Allergy Research Center, Denmark
• Collaborators: National Research Centre for the Working Environment, Denmark; Bispebjerg Hospital; Frederiksberg University Hospital; Arbejdsmiljøforskningsfonden; University of Osnabrueck
• Investigators: Study Director: Jeanne D Johansen, Professor, National Allergy Research Center

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact
• Other Study ID Numbers: P-2019-650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No