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van CCT (UK)


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van CCT (UK)


Clinical differences between atopic and atopiform dermatitis.


- candidate number2235
- NTR NumberNTR765
- ISRCTNISRCTN49428666
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR7-sep-2006
- Secondary IDsN/A 
- Public TitleClinical differences between atopic and atopiform dermatitis.
- Scientific TitleClinical differences between atopic and atopiform dermatitis.
- ACRONYMdifferences between AD and AFD
- hypothesisWe hypothesize that atopiform dermatitis is a separate entity with specific characteristics, which needs recognition in order to be diagnosed and treated appropriately.
- Healt Condition(s) or Problem(s) studiedAtopic dermatitis , Atopiform dermatitis
- Inclusion criteria1. Written informed consent;
2. Age: over 2 years old;
3. Male and female patients;
4. Clinical diagnosis of AD;
5. Cases: former negative or unknown allergen-specific IgE levels in blood;
6. Controls: former positive or unknown allergen-specific IgE levels in blood.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate22-dec-2006
- Target number of participants130
- Interventions1. Percutaneous skin prik test
2. Phadiatop bloodtest
3. Scorad, EASI
4. Diagnositic criteria: Hanifin and Rajka, UK working party's and Millennium criteria
5. Medical History
6. Quality of life: skindex-29 and Sf-36
- Primary outcomeAFD (without allergen-specific IgE) is a separate entity with different, specific characteristics compared to AD (with allergen-specific IgE).
- Secondary outcomeGain more information about the clinical aspects of AFD.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES E.E.A. Brenninkmeijer
- CONTACT for SCIENTIFIC QUERIES E.E.A. Brenninkmeijer
- Sponsor/Initiator Academic Medical Center (AMC), Department of Dermatology
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryIt has been recognized that there are two types of AD; the “extrinsic type” of AD and the “intrinsic type” of AD, in which the “intrinsic type” is characterized by the absence of allergen-specific IgE. Still, there is no consensus whether this “intrinsic type” of AD, which we denominate AFD, concerns a subgroup or it is a completely separate entity. To investigate if AFD and AD are two separate entities, patients with the clinical diagnosis of AD will be divided in two groups on base of allergen-specific IgE levels: cases without allergen-specific IgE and controls with allergen-specific IgE levels. To compare the differences between AD and AFD AD-scoring systems (SCORAD and EASI), diagnostic criteria of AD (Hanifin and Rajka diagnostic criteria, U.K. Working Party’s diagnostic criteria and the Millenium Criteria), extensive medical history and quality of life questionnaires (Skindex-29, PIQoL-AD and SF-36) will be examined.
- Main changes (audit trail)
- RECORD7-sep-2006 - 14-sep-2009


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