Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy

Dermatitis, Allergic Contact Clinical Trial

— ISICA-13  

Official title:

Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953380
• Other study ID #: ISICA-13
• Status: Completed
• Phase: N/A
• First received: September 20, 2013
• Last updated: April 11, 2017
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: April 2017
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with suspected contact allergy

• Age above 18 years

• Participants have given informed consent

Exclusion Criteria:

• Mental or language disabilities

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Allergic Contact

Intervention

Behavioral:
• extended information

Locations

Country	Name	City	State
Sweden	Hudmottagningen SUS	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	clinical improvement	assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.	one year after inclusion
Secondary	quality of life	assessed by questionnaire, Dermatology Life Quality Index (DLQI).	one year after inclusion
Secondary	effect on daily functioning	assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and Dermatology Life Quality Index (DLQI).	one year after inclusion