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.
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
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Tsen-Fang Tsai, MD, 886-2-23123456 ext. 5734, tftsai@yahoo.com
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.
- First posted7 Sep 2006 (estimated)
- Study startAug 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- tsen-fang tsai, md, Principal investigator, National Taiwan University Hospital, Taipei, Taiwan
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atopic Diathesis as Assessed by Serum Th1/Th2 Cytokine Profile on Clinical Manifestation of Psoriasis
- ClinicalTrials.gov ID
- NCT00372580
- Acronym / sponsor ID
- 9461701271
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Dec 2007
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of psoriasis
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood test | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tsen-fang tsai, md principal investigator
National Taiwan University Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
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.