Clinical differences between atopic and atopiform dermatitis

ISRCTN	ISRCTN49428666
DOI	https://doi.org/10.1186/ISRCTN49428666
Secondary identifying numbers	NL754, NTR765

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr E E A Brenninkmeijer
Scientific

Academic Medical Center Amsterdam
Department of Dermatology, A0-223
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 2581
Email	E.E.Brenninkmeijer@amc.uva.nl

Study design	Case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Clinical differences between atopic and atopiform dermatitis
Study objectives	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(s)	Approval received from the Medical Ethical Committee (Medisch Ethische Commissie) on the 24th August 2005 (ref: MEC05/171).
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2006
Completion date	22/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	130
Key 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
Key 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
Date of first enrolment	01/03/2006
Date of final enrolment	22/12/2006

Academic Medical Center Amsterdam

Amsterdam
1105 AZ
Netherlands

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Not defined

Not provided at time of registration

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008	14/01/2021	Yes	No

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The NTR numbers have been added.