NCT04790799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

March 3, 2021

Last Update Submit

November 8, 2023

Conditions

Occupational Contact Dermatitis

Outcome Measures

Primary Outcomes (45)

  • 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

  • Change in severity of handeczema assessed by the photographic guide for severity of handeczema

    Self-assessed photographic guide

    Change between baseline and 3 months

  • Change in severity of handeczema assessed by the photographic guide for severity of handeczema

    Self-assessed photographic guide

    Change between baseline and 6 months

  • Change in severity of handeczema assessed by the photographic guide for severity of handeczema

    Self-assessed photographic guide

    Change between baseline and 9 months

  • Change in severity of handeczema assessed by the photographic guide for severity of handeczema

    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)

    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)

    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)

    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)

    Visual analog Score for severity of handeczema

    Change between baseline and 12 months

  • Amount of corticosteroids prescribed within the last year

    Amount of corticosteroids prescribed wihtin the last year

    Baseline

  • Amount of corticosteroids prescribed within the last 3 months

    Amount of corticosteroids prescribed within the last 3 months

    3 months

  • Amount of corticosteroids prescribed within the last 3 months

    Amount of corticosteroids prescribed within the last 3 months

    6 months

  • Amount of corticosteroids prescribed within the last 3 months

    Amount of corticosteroids prescribed within the last 3 months

    9 months

  • Amount of corticosteroids prescribed within the last 3 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)

    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)

    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)

    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)

    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)

    Skindex-29

    12 months

  • Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)

    "European Quality of Life - 5 Dimensions" (EQ-5D)

    Baseline

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Number of participants with loss of job within the last year

    Self-repported loss of job wihtin the last year

    Baseline

  • Number of participants with loss of job within the last 3 months

    Self-repported loss of job within the last 3 months

    Baseline

  • Number of participants with loss of job within the last 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

    Self-repported loss of job within the last 3 months

    6 months

  • Number of participants with loss of job within the last 3 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

    Self-repported loss of job within the last 3 months

    12 months

  • Amount of sick leave within the last year

    Self-repported amount of sick leave within the last year

    Baseline

  • Amount of sick leave within the last 3 months

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

    3 months

  • Amount of sick leave within the last 3 months

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

    6 months

  • Amount of sick leave within the last 3 months

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

    9 months

  • Amount of sick leave within the last 3 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

    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

    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

    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

    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

    Change of occupation due to occupational contact dermatitis within the last 3 months

    12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Treatment as usual (at a dermatologist office).

Interventions

Treatment at the skin department at Gentofte HospitalOTHER

Treatment in a hospital setting at Gentofte Hospital skin department

Intervention group

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Does not read and write danish
  • Severe psychiatric illness
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital, Skin department

Hellerup, 2900, Denmark

Location

Study Officials

  • Jeanne D Johansen, Professor

    National Allergy Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, Ph.d.-student

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 10, 2021

Study Start

July 2, 2020

Primary Completion

June 14, 2023

Study Completion

June 14, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)