Occupational Hand Eczema - Testing of a Prevention-concept

Occupational Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790799
• Other study ID #: P-2019-650
• Status: Completed
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: June 14, 2023

Study information

• Verified date: November 2023
• Source: National Allergy Research Center, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Occupational Contact Dermatitis

Intervention

Other:
• Treatment at the skin department at Gentofte Hospital
Treatment in a hospital setting at Gentofte Hospital skin department

Locations

Country	Name	City	State
Denmark	Gentofte Hospital, Skin department	Hellerup

Sponsors (6)

Lead Sponsor	Collaborator
National Allergy Research Center, Denmark	Arbejdsmiljøforskningsfonden, Bispebjerg Hospital, Frederiksberg University Hospital, National Research Centre for the Working Environment, Denmark, University of Osnabrueck

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 3 months
Primary	Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 6 months
Primary	Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 9 months
Primary	Change in severity of handeczema assessed by the photographic guide for severity of handeczema	Self-assessed photographic guide	Change between baseline and 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Amount of corticosteroids prescribed within the last year	Amount of corticosteroids prescribed wihtin the last year	Baseline
Primary	Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	3 months
Primary	Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	6 months
Primary	Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	9 months
Primary	Amount of corticosteroids prescribed within the last 3 months	Amount of corticosteroids prescribed within the last 3 months	12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)	"European Quality of Life - 5 Dimensions" (EQ-5D)	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of participants with loss of job within the last year	Self-repported loss of job wihtin the last year	Baseline
Primary	Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	Baseline
Primary	Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	3 months
Primary	Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	6 months
Primary	Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	9 months
Primary	Number of participants with loss of job within the last 3 months	Self-repported loss of job within the last 3 months	12 months
Primary	Amount of sick leave within the last year	Self-repported amount of sick leave within the last year	Baseline
Primary	Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	3 months
Primary	Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	6 months
Primary	Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	9 months
Primary	Amount of sick leave within the last 3 months	Self-repported amount of sick leave within the last 3 months	12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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