Occupational Hand Eczema - Testing of a Prevention-concept

November 8, 2023 updated by: Jojo Biel-Nielsen Dietz, National Allergy Research Center, Denmark

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: Change between baseline and 3 months
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
Time Frame: Change between baseline and 3 months
Self-assessed photographic guide
Change between baseline and 3 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Time Frame: Change between baseline and 6 months
Self-assessed photographic guide
Change between baseline and 6 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Time Frame: Change between baseline and 9 months
Self-assessed photographic guide
Change between baseline and 9 months
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
Time Frame: Change between baseline and 12 months
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)
Time Frame: Change between baseline and 3 months
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)
Time Frame: Change between baseline and 6 months
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)
Time Frame: Change between baseline and 9 months
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)
Time Frame: Change between baseline and 12 months
Visual analog Score for severity of handeczema
Change between baseline and 12 months
Amount of corticosteroids prescribed within the last year
Time Frame: Baseline
Amount of corticosteroids prescribed wihtin the last year
Baseline
Amount of corticosteroids prescribed within the last 3 months
Time Frame: 3 months
Amount of corticosteroids prescribed within the last 3 months
3 months
Amount of corticosteroids prescribed within the last 3 months
Time Frame: 6 months
Amount of corticosteroids prescribed within the last 3 months
6 months
Amount of corticosteroids prescribed within the last 3 months
Time Frame: 9 months
Amount of corticosteroids prescribed within the last 3 months
9 months
Amount of corticosteroids prescribed within the last 3 months
Time Frame: 12 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)
Time Frame: Baseline
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 9 months
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)
Time Frame: 12 months
Skindex-29
12 months
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Time Frame: Baseline
"European Quality of Life - 5 Dimensions" (EQ-5D)
Baseline
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
Time Frame: 3 months
"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)
Time Frame: 6 months
"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)
Time Frame: 9 months
"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)
Time Frame: 12 months
"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)
Time Frame: Baseline
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)
Time Frame: 3 months
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)
Time Frame: 6 months
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)
Time Frame: 9 months
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)
Time Frame: 12 months
Dermatology life quality index (DLQI)
12 months
Number of participants with loss of job within the last year
Time Frame: Baseline
Self-repported loss of job wihtin the last year
Baseline
Number of participants with loss of job within the last 3 months
Time Frame: Baseline
Self-repported loss of job within the last 3 months
Baseline
Number of participants with loss of job within the last 3 months
Time Frame: 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
Time Frame: 6 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
Time Frame: 9 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
Time Frame: 12 months
Self-repported loss of job within the last 3 months
12 months
Amount of sick leave within the last year
Time Frame: Baseline
Self-repported amount of sick leave within the last year
Baseline
Amount of sick leave within the last 3 months
Time Frame: 3 months
Self-repported amount of sick leave within the last 3 months
3 months
Amount of sick leave within the last 3 months
Time Frame: 6 months
Self-repported amount of sick leave within the last 3 months
6 months
Amount of sick leave within the last 3 months
Time Frame: 9 months
Self-repported amount of sick leave within the last 3 months
9 months
Amount of sick leave within the last 3 months
Time Frame: 12 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
Time Frame: Baseline
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
Time Frame: 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
Time Frame: 6 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
Time Frame: 9 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
Time Frame: 12 months
Change of occupation due to occupational contact dermatitis within the last 3 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Allergy Research Center, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Centre for the Working Environment, Denmark
Bispebjerg Hospital
Frederiksberg University Hospital
Arbejdsmiljøforskningsfonden
University of Osnabrueck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jeanne D Johansen, Professor, National Allergy Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings