search
Back to results

Occupational Hand Eczema - Testing of a Prevention-concept

Primary Purpose

Occupational Contact Dermatitis

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Treatment at the skin department at Gentofte Hospital
Sponsored by
National Allergy Research Center, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Occupational Contact Dermatitis

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gentofte Hospital, Skin departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

Treatment as usual (at a dermatologist office).

Outcomes

Primary Outcome Measures

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 in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Self-assessed photographic guide
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 in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Visual analog Score for severity of handeczema
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 in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Visual analog Score for severity of handeczema
Amount of corticosteroids prescribed within the last year
Amount of corticosteroids prescribed wihtin the last year
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 months
Amount of corticosteroids prescribed within the last 3 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)
Skindex-29
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
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
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
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
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"European Quality of Life - 5 Dimensions" (EQ-5D)
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
"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)
Dermatology life quality index (DLQI)
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)
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)
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)
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)
Number of participants with loss of job within the last year
Self-repported loss of job wihtin the last year
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Number of participants with loss of job within the last 3 months
Self-repported loss of job within the last 3 months
Amount of sick leave within the last year
Self-repported amount of sick leave within the last year
Amount of sick leave within the last 3 months
Self-repported amount of sick leave within the last 3 months
Amount of sick leave within the last 3 months
Self-repported amount of sick leave within the last 3 months
Amount of sick leave within the last 3 months
Self-repported amount of sick leave within the last 3 months
Amount of sick leave within the last 3 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 year
Change of occupation due to occupational contact dermatitis within the last year
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2021
Last Updated
March 10, 2021
Sponsor
National Allergy Research Center, Denmark
Collaborators
Arbejdsmiljøforskningsfonden, Bispebjerg Hospital, Frederiksberg University Hospital, National Research Centre for the Working Environment, Denmark, University of Osnabrueck
search

1. Study Identification

Unique Protocol Identification Number
NCT04790799
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Allergy Research Center, Denmark
Collaborators
Arbejdsmiljøforskningsfonden, Bispebjerg Hospital, Frederiksberg University Hospital, National Research Centre for the Working Environment, Denmark, University of Osnabrueck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Contact Dermatitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Treatment as usual (at a dermatologist office).
Intervention Type
Other
Intervention Name(s)
Treatment at the skin department at Gentofte Hospital
Intervention Description
Treatment in a hospital setting at Gentofte Hospital skin department
Primary Outcome Measure Information:
Title
Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)
Description
The hand eczema severity index (HECSI)
Time Frame
Change between baseline and 3 months
Title
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Description
Self-assessed photographic guide
Time Frame
Change between baseline and 3 months
Title
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Description
Self-assessed photographic guide
Time Frame
Change between baseline and 6 months
Title
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Description
Self-assessed photographic guide
Time Frame
Change between baseline and 9 months
Title
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Description
Self-assessed photographic guide
Time Frame
Change between baseline and 12 months
Title
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Description
Visual analog Score for severity of handeczema
Time Frame
Change between baseline and 3 months
Title
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Description
Visual analog Score for severity of handeczema
Time Frame
Change between baseline and 6 months
Title
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Description
Visual analog Score for severity of handeczema
Time Frame
Change between baseline and 9 months
Title
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
Description
Visual analog Score for severity of handeczema
Time Frame
Change between baseline and 12 months
Title
Amount of corticosteroids prescribed within the last year
Description
Amount of corticosteroids prescribed wihtin the last year
Time Frame
Baseline
Title
Amount of corticosteroids prescribed within the last 3 months
Description
Amount of corticosteroids prescribed within the last 3 months
Time Frame
3 months
Title
Amount of corticosteroids prescribed within the last 3 months
Description
Amount of corticosteroids prescribed within the last 3 months
Time Frame
6 months
Title
Amount of corticosteroids prescribed within the last 3 months
Description
Amount of corticosteroids prescribed within the last 3 months
Time Frame
9 months
Title
Amount of corticosteroids prescribed within the last 3 months
Description
Amount of corticosteroids prescribed within the last 3 months
Time Frame
12 months
Title
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)
Description
Skindex-29
Time Frame
Baseline
Title
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)
Description
Skindex-29
Time Frame
3 months
Title
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)
Description
Skindex-29
Time Frame
6 months
Title
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)
Description
Skindex-29
Time Frame
9 months
Title
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)
Description
Skindex-29
Time Frame
12 months
Title
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Description
"European Quality of Life - 5 Dimensions" (EQ-5D)
Time Frame
Baseline
Title
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Description
"European Quality of Life - 5 Dimensions" (EQ-5D)
Time Frame
3 months
Title
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Description
"European Quality of Life - 5 Dimensions" (EQ-5D)
Time Frame
6 months
Title
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Description
"European Quality of Life - 5 Dimensions" (EQ-5D)
Time Frame
9 months
Title
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Description
"European Quality of Life - 5 Dimensions" (EQ-5D)
Time Frame
12 months
Title
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)
Description
Dermatology life quality index (DLQI)
Time Frame
Baseline
Title
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)
Description
Dermatology life quality index (DLQI)
Time Frame
3 months
Title
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)
Description
Dermatology life quality index (DLQI)
Time Frame
6 months
Title
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)
Description
Dermatology life quality index (DLQI)
Time Frame
9 months
Title
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)
Description
Dermatology life quality index (DLQI)
Time Frame
12 months
Title
Number of participants with loss of job within the last year
Description
Self-repported loss of job wihtin the last year
Time Frame
Baseline
Title
Number of participants with loss of job within the last 3 months
Description
Self-repported loss of job within the last 3 months
Time Frame
Baseline
Title
Number of participants with loss of job within the last 3 months
Description
Self-repported loss of job within the last 3 months
Time Frame
3 months
Title
Number of participants with loss of job within the last 3 months
Description
Self-repported loss of job within the last 3 months
Time Frame
6 months
Title
Number of participants with loss of job within the last 3 months
Description
Self-repported loss of job within the last 3 months
Time Frame
9 months
Title
Number of participants with loss of job within the last 3 months
Description
Self-repported loss of job within the last 3 months
Time Frame
12 months
Title
Amount of sick leave within the last year
Description
Self-repported amount of sick leave within the last year
Time Frame
Baseline
Title
Amount of sick leave within the last 3 months
Description
Self-repported amount of sick leave within the last 3 months
Time Frame
3 months
Title
Amount of sick leave within the last 3 months
Description
Self-repported amount of sick leave within the last 3 months
Time Frame
6 months
Title
Amount of sick leave within the last 3 months
Description
Self-repported amount of sick leave within the last 3 months
Time Frame
9 months
Title
Amount of sick leave within the last 3 months
Description
Self-repported amount of sick leave within the last 3 months
Time Frame
12 months
Title
Number of participants with change of occupation due to occupational contact dermatitis within the last year
Description
Change of occupation due to occupational contact dermatitis within the last year
Time Frame
Baseline
Title
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Description
Change of occupation due to occupational contact dermatitis within the last 3 months
Time Frame
3 months
Title
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Description
Change of occupation due to occupational contact dermatitis within the last 3 months
Time Frame
6 months
Title
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Description
Change of occupation due to occupational contact dermatitis within the last 3 months
Time Frame
9 months
Title
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
Description
Change of occupation due to occupational contact dermatitis within the last 3 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jojo B Dietz, M.D.
Phone
+45 38 67 37 55
Email
jojo.biel-nielsen.dietz@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne D Johansen, Professor
Organizational Affiliation
National Allergy Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Gentofte Hospital, Skin department
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jojo B Dietz, M.D.
Phone
+45 38673755
Email
jojo.biel-nielsen.dietz@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Occupational Hand Eczema - Testing of a Prevention-concept

We'll reach out to this number within 24 hrs