A 24-week Single-blind Trial of Prevention of Hand Eczema in Cleaners
NCT ID: NCT05763914
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
234 participants
INTERVENTIONAL
2022-11-14
2023-06-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema
NCT01012453
A Randomised Clinical Trial on the Effect of Group Education on Patients With Occupational Hand Eczema
NCT01899287
Hand Eczema in the Health Care Sector
NCT04449575
Occupational Hand Eczema - Testing of a Prevention-concept
NCT04790799
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis
NCT00843466
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Picture-based prevention education and an educational course
The participants will have access to picture-based prevention education, and at the same time, they will participate in an educational course.
Change in the incidence of hand eczema
Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.
Change in severity of hand eczema
Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.
Change in the number of self-reported days with absence from work due to having hand eczema
Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.
Change in the number of participants being forced to change their job due to having hand eczema
Self-reported change of job due to having hand eczema. Change between baseline and 6 months.
Change in The Quality Of Life in in relation to hand eczema
Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.
Change in the level of knowledge regarding skin care and protection.
Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.
Group 2: Picture-based prevention education only (no educational course)
The participants will only have access to picture-based prevention education and will not participate in any educational course.
Change in the incidence of hand eczema
Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.
Change in severity of hand eczema
Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.
Change in the number of self-reported days with absence from work due to having hand eczema
Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.
Change in the number of participants being forced to change their job due to having hand eczema
Self-reported change of job due to having hand eczema. Change between baseline and 6 months.
Change in The Quality Of Life in in relation to hand eczema
Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.
Change in the level of knowledge regarding skin care and protection.
Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.
Group 3: Placebo (control)
The participants will not have access to picture-based prevention education and do not participate in any educational course.
Change in the incidence of hand eczema
Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.
Change in severity of hand eczema
Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.
Change in the number of self-reported days with absence from work due to having hand eczema
Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.
Change in the number of participants being forced to change their job due to having hand eczema
Self-reported change of job due to having hand eczema. Change between baseline and 6 months.
Change in The Quality Of Life in in relation to hand eczema
Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.
Change in the level of knowledge regarding skin care and protection.
Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Change in the incidence of hand eczema
Assessed by the self-reported cases of newly-developed hand eczema. Change between baseline and 6 months.
Change in severity of hand eczema
Assessed by using the Hand Eczema Severity Index (HECSI). HECSI score: 0-360 points (0 best, 360 worst). Change between baseline and 6 months.
Change in the number of self-reported days with absence from work due to having hand eczema
Self-reported total number of sick days due to having hand eczema. Change between baseline and 6 months.
Change in the number of participants being forced to change their job due to having hand eczema
Self-reported change of job due to having hand eczema. Change between baseline and 6 months.
Change in The Quality Of Life in in relation to hand eczema
Assessed by using Hand Eczema Questionnaire (QolHEQ). Change between baseline and 6 months.
Change in the level of knowledge regarding skin care and protection.
Self-reported level of knowledge regarding skin care and protection. Change between baseline and 6 months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sufficient Danish skills
* Written informed consent
Exclusion Criteria
* Pregnancy
* Other skin diseases on the hands
* Receiving Immunomodulatory therapies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Copenhagen
OTHER
Danish Working Environment Fund
UNKNOWN
Zealand University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Farnam Barati Sedeh
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristina Sophie Ibler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleaning departments at Køge, Slagelse and Holbæk hospitals
Køge, Region Sjælland, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20205100702
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.