Condition category
Skin and Connective Tissue Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
17/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E E A Brenninkmeijer

ORCID ID

Contact details

Academic Medical Center Amsterdam
Department of Dermatology
A0-223
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 2581
E.E.Brenninkmeijer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

We hypothesise that AtopiForm Dermatitis (AFD) is a separate entity with specific characteristics, which needs recognition in order to be diagnosed and treated appropriately.

Ethics approval

Approval received from the Medical Ethical Committee (Medisch Ethische Commissie) on the 24th August 2005 (ref: MEC05/171).

Study design

Case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Atopic dermatitis , Atopiform dermatitis

Intervention

1. Percutaneous skin prick test
2. Phadiatop blood test
3. SCORing Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI)
4. Diagnositic criteria: Hanifin and Rajka, United Kingdom working party's and Millennium criteria
5. Medical History
6. Quality of life: skindex-29 questionnaire and Short Form health survey (SF-36)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

AFD (without allergen-specific IgE) is a separate entity with different, specific characteristics compared to AD (with allergen-specific IgE).

Secondary outcome measures

Gain more information about the clinical aspects of AFD.

Overall trial start date

01/03/2006

Overall trial end date

22/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Age: over two years old
3. Male and female patients
4. Clinical diagnosis of Atopic Dermatitis (AD)
5. Cases: former negative or unknown allergen-specific Immunoglobulin E (IgE) levels in blood
6. Controls: former positive or unknown allergen-specific IgE levels in blood

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Other skin diseases, which interfere the study
2. Patients unable to comply with the requirements of the study
3. Treatment with systemic corticosteroids or phototherapy within four weeks before performing the skin prick test
4. Treatment with oral anti-histamines within 48-hour before performing the skin prick test

Recruitment start date

01/03/2006

Recruitment end date

22/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center Amsterdam
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Department of Dermatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes