Dermatitis, Allergic ContactISICA-13NCT01953380
Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy
A study testing extended information in people with Dermatitis, Allergic Contact, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Allergic Contact
- What is being tested?
- extended information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected contact allergy
- Age above 18 years
- Participants have given informed consent
Who cannot join
- Mental or language disabilities
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether extended information given to patients with contact allergy improves knowledge, treatment efficacy and daily functioning.
- Conditions
- Dermatitis, Allergic Contact
- Being tested
- extended information
- Keywords
- Intervention Studies, Eczema, Randomized Controlled Trial, Knowledge, Quality of Life
- Medical subject headings
- Dermatitis, Allergic Contact, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended informationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| extended information | Active comparator | Extended information on specific allergy Receives: Behavioral: extended information |
| Information according to clin. routine | No intervention | Information according to clinical routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year after inclusion
Secondary outcomes (3)
clinical improvement
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
Measured: one year after inclusion
quality of life
assessed by questionnaire, Dermatology Life Quality Index (DLQI).
Measured: one year after inclusion
effect on daily functioning
assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and Dermatology Life Quality Index (DLQI).
Measured: one year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, Allergic ContactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Sonesson, Region Skane
- Investigators
- Andreas Sonesson, MD PhD, Principal investigator, Region Skåne, Hudkliniken SUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953380
- Sponsor's protocol ID
- ISICA-13
- Acronym
- ISICA-13
- Status last verified
- Apr 2017
- First submitted
- 20 Sep 2013
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35794786
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy
- ClinicalTrials.gov ID
- NCT01953380
- Acronym / sponsor ID
- ISICA-13 / ISICA-13
- Conditions
- Dermatitis, Allergic Contact
- Keywords
- Intervention Studies, Eczema, Randomized Controlled Trial, Knowledge, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether extended information given to patients with contact allergy improves knowledge, treatment efficacy and daily functioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended information | Active comparator | Behavioral: extended informationExtended information on specific allergy |
| Information according to clin. routine | No intervention | –Information according to clinical routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspected contact allergy
- Age above 18 years
- Participants have given informed consent
Key exclusion criteria (1 listed)
- Mental or language disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended information | Behavioural | extended information |
Primary outcome
knowledge
Time frame: one year after inclusion
knowledge about specific contact allergies and exposure, assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.
3 secondary outcomes
clinical improvement
Time frame: one year after inclusion
quality of life
Time frame: one year after inclusion
effect on daily functioning
Time frame: one year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Derived from this study: PubMed 35794786Mossing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Sonesson, MD PhD principal investigator
Region Skåne, Hudkliniken SUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extended information in people with Dermatitis, Allergic Contact, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge (time frame: one year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01953380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.