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PsoriasisNCT00372580

Effect of Atopic Diathesis as Assessed by Serum Th1/Th2 Cytokine Profile on Clinical Manifestation of Psoriasis

An observational study of Psoriasis, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Psoriasis is a chronic inflammatory skin disease characterized by the formation of scaly and erythematous plaques. A Th1-cell mediated process is believed to be involved in the pathogenesis of psoriasis. It is mainly because of the detected Th1 cytokine profile in the sera and tissue. Read more about this study

Who is it for?
Ages 0 years and older
Conditions the study is for
Psoriasis
What is being tested?
blood test
Type of treatment
Surgery or procedure
How many people
110 participants
Where
1 siteTaiwan
Study dates
Aug 2006to Dec 2007
Phase
Observational
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 0 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical diagnosis of psoriasis

Who cannot join

  • no

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, Taipei, 100

    Tsen-Fang Tsai, MD, 886-2-23123456 ext. 5734, tftsai@yahoo.com

    Recruiting

Other trials in Taiwan

About this study

Psoriasis is a chronic inflammatory skin disease characterized by the formation of scaly and erythematous plaques. A Th1-cell mediated process is believed to be involved in the pathogenesis of psoriasis. It is mainly because of the detected Th1 cytokine profile in the sera and tissue. Epidemiologic studies also showed a significantly decreased incidence of atopic dermatitis. According to the Th1 and Th2 dogma, psoriasis and atopic dermatitis are two mutually exclusive dermatoses. However, the simple dichotomy of Th1 and Th2 in the pathogenesis of psoriasis and atopic dermatitis may be overly simplistic.1. Recent genetic studies suggest striking overlapping genetic loci for both psoriasis and atopic dermatitis. In fact, atopic dermatitis and psoriasis shared more genetic similarity than atopic dermatitis and asthma. 2. It is indeed, difficult to find patients with both typical atopic dermatitis and psoriasis. However, asthma is not so rarely encountered in psoriasis. And asthma is one of the hallmark in the diagnosis of atopic dermatitis. 3. The cytokine profile in long-standing atopic dermatitis shifted to a Th1 profile. A mixed Th1 and Th2 chemokine profiles are present in atopic dermatitis. Scratch can result in a Th1 infiltrate in animal model. 4. Patients with erythrodermic psoriasis has a higher percentage of elevated IgE levels. And tissue or peripheral eosinophilia might be present. 5. Eczema is a known precipitating factor of psoriasis. Areas of atopic dermatitis in childhood may serve as koebernizing loci for the future development of psoriasis. And in adulthood, since the main pathologic event of asthma is in the aerorespiratory tract, the presence of Th2 cytokine profile does not seemingly affect the build up of a Th1 profile in the skin of psoriasis.

Read the detailed description

It has been suggested that psoriasis is not a homogeneous disease. It is a constellation of diseases sharing similar pathologic findings. Clinical distinct entities of psoriasis include pustular psoriasis, guttate psoriasis, psoriasis vulgaris, erythrodermic psoriasis, inverse psoraisis, sebopsoriasis. Recent studies also showed a different cytokine profile in small and large plaque psoriasis. It is also suggested that the thickness of psoriatic plaques is also genetically pre-determined. In my daily practice, nummular/eczematous (or thin plaque), inverse and erythrodermic psoriasis seems to be more common in the presence of an asthma/atopy history. The present study was designed to find out the influence of atopic diathess on the phenotypic manifestation of psoriasis. In the absence of typical atopic eczema lesions in patients of psoriasis, the Th2 cytokine profile and serum IgE level as well as personal and family history of atopy (i.e. asthma, allergic rhinitis, hay fever, atopic dermatitis) and the presence and degree of itch will also be assayed and correlated with the clinical manifestation. At least one hundred consecutive psoriatic patients with or without atopic diathesis will be recruited. The definition of variants of psoriasis other than psoriasis vulgaris is as follows: 1. Pustular psoriasis: lesions showing clinical pustular as the main form, excluding pustular transformation secondary to treatment.2. Erythodermic psoriasis: thin plaques covering more than 90% of BSA at its worst and at least 50% when seen during the study3. Inverse psoriasis: psoriasis mainly over the large skin folds, including the groins, breast, foreskin, interdigital (psoriasis alba) and subauricular areas. 4. Sebopsoriasis: lesions mainly confined to the seborrheic areas, i.e. scalp, ears, retroauricular folds, glabella, eyebrows, nasal folds, presternal and intersscapular areas. Lesions confined only to the scalp will be excluded. 5. Guttate psoriasis: acute onset of multiple lesions usually not wider than 1 cm6. Nummular psoriasis: discoid thin plaques (PSAI: thickness mostly 1), usually 4-5 cms wide, with somewhat exudative surface sometimes annular and preferentially located on the limbs. In case of uncertainty, pathology will be performed to make the diagnosis before enrollment. 7. Thin plaque psoriasis: similar to psoriasis vulgaris, but the thickness of individual plaques are no more than grade 2 in PASI except on the elbows, knees and scalp. 8. Small plaque psoriasis: similar to guttate psoriasis but the plaques are larger (1-5 cm) and has a more chronic course.9. Other psoriasis: this includes figurate erythema like psoriasis, psoriasis unguium only, etc.

Conditions
Psoriasis
Being tested
blood test
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood testProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2006 (estimated)
  2. Study startAug 2006
  3. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
110 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00372580
Sponsor's protocol ID
9461701271
Status last verified
Sep 2006
First submitted
5 Sep 2006
Last updated
7 Sep 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by National Taiwan University Hospital at 1 site in Taiwan.

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 1 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: status not confirmed, as of the sponsor's last update on 7 Sep 2006. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact TSEN-FANG Tsai, MD (02-23123456 ext. 5734, Tftsai@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
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 7 Sep 2006.

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