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Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy (ISICA-13)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Andreas Sonesson, Region Skane
ClinicalTrials.gov Identifier:
NCT01953380
First received: September 20, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Dermatitis, Allergic Contact
Behavioral: extended information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • knowledge [ Time Frame: one year after inclusion ] [ Designated as safety issue: No ]
    knowledge about specific contact allergies and exposure, assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.


Secondary Outcome Measures:
  • clinical improvement [ Time Frame: one year after inclusion ] [ Designated as safety issue: No ]
    assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.

  • quality of life [ Time Frame: one year after inclusion ] [ Designated as safety issue: No ]
    assessed by questionnaire, Dermatology Life Quality Index (DLQI).

  • effect on daily functioning [ Time Frame: one year after inclusion ] [ Designated as safety issue: No ]
    assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and Dermatology Life Quality Index (DLQI).


Estimated Enrollment: 600
Study Start Date: October 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: extended information
Extended information on specific allergy
Behavioral: extended information
No Intervention: Information according to clin. routine
Information according to clinical routine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental or language disabilities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953380

Contacts
Contact: Andreas Sonesson, MD PhD +4646171134 andreas.sonesson@med.lu.se
Contact: William Troensegaard, MD +4646171134 william.troensegaard@skane.se

Locations
Sweden
Hudmottagningen SUS Recruiting
Lund, Skåne, Sweden, 22185
Principal Investigator: William Troensegaard, MD         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Andreas Sonesson, MD PhD Region Skåne, Hudkliniken SUS
  More Information

No publications provided

Responsible Party: Andreas Sonesson, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01953380     History of Changes
Other Study ID Numbers: ISICA-13
Study First Received: September 20, 2013
Last Updated: May 14, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Intervention Studies
Eczema
Randomized Controlled Trial
Knowledge
Quality of Life

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Dermatitis, Contact
Hypersensitivity
Hypersensitivity, Delayed
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on November 20, 2014