Skip to main content
OpenTrials
Completed

NCT Number: NCT04790799

Occupational Hand Eczema - Testing of a Prevention-concept

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Occupational Contact Dermatitis

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital, Skin department

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment at the skin department at Gentofte Hospital

Other

Treatment in a hospital setting at Gentofte Hospital skin department

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Amount of corticosteroids prescribed within the last year

    Time frame: Baseline

    Amount of corticosteroids prescribed wihtin the last year

  11. Amount of corticosteroids prescribed within the last 3 months

    Time frame: 3 months

    Amount of corticosteroids prescribed within the last 3 months

  12. Amount of corticosteroids prescribed within the last 3 months

    Time frame: 6 months

    Amount of corticosteroids prescribed within the last 3 months

  13. Amount of corticosteroids prescribed within the last 3 months

    Time frame: 9 months

    Amount of corticosteroids prescribed within the last 3 months

  14. Amount of corticosteroids prescribed within the last 3 months

    Time frame: 12 months

    Amount of corticosteroids prescribed within the last 3 months

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. Number of participants with loss of job within the last year

    Time frame: Baseline

    Self-repported loss of job wihtin the last year

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. Amount of sick leave within the last year

    Time frame: Baseline

    Self-repported amount of sick leave within the last year

  37. Amount of sick leave within the last 3 months

    Time frame: 3 months

    Self-repported amount of sick leave within the last 3 months

  38. Amount of sick leave within the last 3 months

    Time frame: 6 months

    Self-repported amount of sick leave within the last 3 months

  39. Amount of sick leave within the last 3 months

    Time frame: 9 months

    Self-repported amount of sick leave within the last 3 months

  40. Amount of sick leave within the last 3 months

    Time frame: 12 months

    Self-repported amount of sick leave within the last 3 months

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

Sponsors and collaborators

Lead sponsor

National Allergy Research Center, Denmark

Other

Collaborators

  • Arbejdsmiljøforskningsfonden
  • Bispebjerg Hospital
  • Frederiksberg University Hospital
  • National Research Centre for the Working Environment, Denmark
  • University of Osnabrueck

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2021
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.