NCT01953380

Brief Summary

The purpose of this study is to determine whether extended information given to patients with contact allergy improves knowledge, treatment efficacy and daily functioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

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

First Submitted

Initial submission to the registry

September 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

September 20, 2013

Last Update Submit

April 11, 2017

Conditions

Dermatitis, Allergic Contact

Keywords

Intervention StudiesEczemaRandomized Controlled TrialKnowledgeQuality of Life

Outcome Measures

Primary Outcomes (1)

  • knowledge

    knowledge about specific contact allergies and exposure, assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.

    one year after inclusion

Secondary Outcomes (3)

  • clinical improvement

    one year after inclusion

  • quality of life

    one year after inclusion

  • effect on daily functioning

    one year after inclusion

Study Arms (2)

extended information

ACTIVE COMPARATOR

Extended information on specific allergy

Behavioral: extended information

Information according to clin. routine

NO INTERVENTION

Information according to clinical routine

Interventions

extended informationBEHAVIORAL
extended information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected contact allergy
  • Age above 18 years
  • Participants have given informed consent

You may not qualify if:

  • Mental or language disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hudmottagningen SUS

Lund, Skåne County, 22185, Sweden

Location

Related Publications (1)

  • Mossing K, Dizdarevic A, Svensson A, Sonesson A. Impact on quality of life of an intervention providing additional information to patients with allergic contact dermatitis; a randomized clinical trial. J Eur Acad Dermatol Venereol. 2022 Nov;36(11):2166-2171. doi: 10.1111/jdv.18412. Epub 2022 Jul 18.

    PMID: 35794786DERIVED

MeSH Terms

Conditions

Dermatitis, Allergic ContactEczema

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Andreas Sonesson, MD PhD

    Region Skåne, Hudkliniken SUS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 20, 2013

First Posted

October 1, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

SE(1)