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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list