NCT01012453

Brief Summary

Objectives and perspective:

  • Irritant contact dermatitis is more common than allergic contact dermatitis.
  • The combination of precise classification (subtyping of HE) and individual counseling will have a positive impact on the prognosis of hand eczema.
  • The positive impact on the prognosis of hand eczema will have a positive impact on quality of life (QoL).
  • The knowledge of protective behavior will increase.
  • Education in a skin care program will have a positive impact on skin protective behavior.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

October 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

Enrollment Period

Same day

First QC Date

November 12, 2009

Last Update Submit

November 12, 2009

Conditions

EczemaDermatitisSkin Disease

Keywords

Hand eczemaHand dermatitisOccupational skin diseaseskindisease in health care workersoccupational hand dermatitisoccupational hand eczema

Outcome Measures

Primary Outcomes (1)

  • Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.

    6 months

Secondary Outcomes (1)

  • Secondary outcomes: -Subjective assessment of disease severity (HE) -Number of eruptions through the past three months -Knowledge of skin protection -Skinprotective behaviour -Quality of life

    6 months

Study Arms (1)

Hand Eczema in health care workers

NO INTERVENTION
Behavioral: A randomised clinical trial of the effect of classification and individual counselling

Interventions

A randomised clinical trial of the effect of classification and individual counsellingBEHAVIORAL

The trial to be conducted is a randomised single-blinded parallel study. It is divided in two stages, T = 0 and follow-up at T = 6 months. All included participants will have a clinical examination at the beginning and at follow-up in the trial. Half of the participants will be randomised to intervention, the other half to control. The participants in the intervention group will, after the first clinical examination, pass on directly to the intervention which includes an allergological examination (patch and prick testing). Three days later they will be examined by a physician who will interpret the patch test and give a thorough, individual guidance in skin protection and occupational safety. The clinical examination of all participants at follow-up will reveal the difference in outcomes in the intervention and the control group.

Hand Eczema in health care workers

Eligibility Criteria

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

You may qualify if:

  • Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
  • Informed written consent must be present in order to participate.

You may not qualify if:

  • Pregnancy
  • Systemic use of immunosuppressive drugs
  • Systemic use of retinoids
  • Active psoriatic lesions on the hands
  • Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
  • Lack of informed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Holbaek Hospital

Holbæk, 4300, Denmark

NOT YET RECRUITING

Koege Hospital

Koege, 4600, Denmark

NOT YET RECRUITING

Dermatological Department, Roskilde County Hospital

Roskilde, 4000, Denmark

RECRUITING

Related Publications (2)

  • Ibler KS, Jemec GB, Diepgen TL, Gluud C, Lindschou Hansen J, Winkel P, Thomsen SF, Agner T. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ. 2012 Dec 12;345:e7822. doi: 10.1136/bmj.e7822.

    PMID: 23236031DERIVED

  • Ibler KS, Agner T, Hansen JL, Gluud C. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema. BMC Dermatol. 2010 Aug 31;10:8. doi: 10.1186/1471-5945-10-8.

    PMID: 20807407DERIVED

MeSH Terms

Conditions

EczemaDermatitisSkin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin Diseases, Eczematous

Central Study Contacts

Kristina Sophie Ibler, MD, Ph.d-student

CONTACT

+45-47322600ksi@regionsjaelland.dk

Tove Agner, MD, DM Science

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2009

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations

DK(3)