Occupational Hand Eczema - Testing of a Prevention-concept

NCT ID: NCT04790799

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-02

Study Completion Date

2023-06-14

Brief Summary

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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

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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.

Conditions

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Occupational Contact Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Treatment at the skin department at Gentofte Hospital

Intervention Type OTHER

Treatment in a hospital setting at Gentofte Hospital skin department

Control group

Treatment as usual (at a dermatologist office).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Treatment at the skin department at Gentofte Hospital

Treatment in a hospital setting at Gentofte Hospital skin department

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arbejdsmiljøforskningsfonden

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Frederiksberg University Hospital

OTHER

Sponsor Role collaborator

National Research Centre for the Working Environment, Denmark

OTHER_GOV

Sponsor Role collaborator

University of Osnabrueck

OTHER

Sponsor Role collaborator

National Allergy Research Center, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Jojo Biel-Nielsen Dietz

Medical doctor, Ph.d.-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeanne D Johansen, Professor

Role: STUDY_DIRECTOR

National Allergy Research Center

Locations

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Gentofte Hospital, Skin department

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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P-2019-650

Identifier Type: -

Identifier Source: org_study_id

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