PsoriasisNCT01920906
Comparative Analysis of Small and Large Plaque Psoriasis
A study testing Skin biopsy and blood test in people with Psoriasis, run by Rockefeller University at 1 site in United States.
Trial summary
Psoriasis is a chronic, debilitating skin disorder with an estimated prevalence of 2%. Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into plaques of varying sizes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Skin biopsy and blood test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2015
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified as Korean (defined as being Korean and both parents are Korean)
- History of small and/or large plaque psoriasis, for at least six months
- At least 18 years of age
- No treatment with topical steroids or vitamin D analogues for at least 2 weeks prior to entering the study.
- No treatment with systemic therapies, including phototherapy, acitretin, cyclosporine, methotrexate and biologics 4 weeks prior to entering the study. Among biologics, Ustekinumab (Stelara®) requires a longer washout period of 12 weeks.
Who cannot join
- Erythrodermic, or pustular psoriasis as the sole or predominant form of psoriasis.
- Photosensitizing illnesses such as lupus, polymorphous light eruption, or any disease known to be worsened by UV light exposure.
- History of malignant melanoma.
- Pregnancy.
- Immunocompromising diseases such as HIV infection.
- Inflammatory diseases such as but not limited to Crohn's Disease, Multiple Sclerosis, Rheumatoid Arthritis, Hashimoto's Disease.
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data. Participants taking medications that induce photosensitivity may be included after careful review.
- Poorly controlled medical conditions of any kind.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Psoriasis is a chronic, debilitating skin disorder with an estimated prevalence of 2%. Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into plaques of varying sizes. Despite the great strides in the studies for psoriasis, it is still unclear why psoriatic skin lesions start with small macules and then spread peripherally.
To study peripheral spreading of psoriasis, investigators plan to study small plaque psoriasis in comparison to large plaque psoriasis in the Korean population. Large plaque psoriasis is the most common form of psoriasis, seen in approximately 90% of all psoriasis participants. Large psoriatic plaques are >5 cm in size and localize to the extensor aspects of the elbows, knees, scalp, and genital area. On the other hand, small plaque psoriasis is the common or typical form of psoriasis that occurs particularly in Korea and other Asian countries. Korean small plaque psoriasis, even when chronic, remains <2 cm in size and is widely distributed on the upper trunk and proximal extremities.
Read more
Investigators hypothesize that the expression of immune-related genes are different between small and large plaque psoriasis. The study of a genetically homogeneous cohort, characterized by the relatively high prevalence of small plaque psoriasis in the Korean population, may filter out spurious signals while allowing for significant associations to emerge from a relatively low number of participants.
By comparing small and large plaque psoriasis, it is expected this study could lead to new understandings of the mechanisms involved in spreading of psoriatic plaques and provide new insights into psoriasis development.
Read the detailed description
Psoriasis is a common chronic skin disorder with an estimated prevalence in populations of approximately 2%. Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into plaques of varying sizes in diameter from one to several centimeters.
Despite the great strides in the studies for psoriasis, it is still unclear why psoriatic skin lesions start with small macules and then spread peripherally. The occurrence of psoriasis is thought to be the pathological consequence of an exaggerated immune response as activated T cells, monocytes, neutrophils, and dendritic cells produce inflammatory cytokines that drive the additional recruitment of inflammatory cells, further elaboration of proinflammatory mediators, and the proliferation of keratinocytes. However, pathogenetic mechanism for peripheral spreading of psoriasis needs to be further elucidated.
To study peripheral spreading of psoriasis, investigators plan to study "small plaque psoriasis" and compare it to "large plaque psoriasis" in the Korean population.
Psoriasis vulgaris, so-called "large plaque psoriasis", is the most common form of psoriasis, seen in approximately 90% of all psoriasis patients. Red, scaly, symmetrically distributed plaques are usually larger than 5 cm in diameter and characteristically localized to the extensor aspects of the extremities, particularly the elbows and knees, along with scalp, lower lumbosacral, buttocks, and genital involvement. Approximately 1/4 to 1/3 of large plaque psoriasis participants have involvement of over 5% of their body surface area (BSA), and disease of this extent is frequently painful and physically and/or socially debilitating to a degree comparable with other chronic medical conditions.
On the other hand, "small plaque psoriasis" is the common or typical form of psoriasis that occurs in adults particularly in Korea and other Asian countries. Korean small plaque psoriasis, even when chronic, remain <2 cm in size and widely distributed on upper trunk and proximal extremities. Small plaque psoriasis is less severe than large plaque psoriasis, as it usually responds to phototherapy and more potent therapies are rarely needed.
It is also noteworthy that there are well-known human leukocyte antigen (HLA) differences in Caucasians in comparison with Asian participants with psoriasis, and a unique HLA haplotype has been described in Korean participants with psoriasis. Furthermore, an allele of an HLA-related gene, known as major histocompatibility complex I chain-related gene A, is known as a susceptibility marker in Korean and Chinese participants with psoriasis, but not in Spanish participants.
For a more comprehensive analysis of the difference between small and large plaque psoriasis, investigators plan to compare these two different types of psoriasis only in the Korean population. The study of a genetically homogeneous cohort, characterized by the relatively high prevalence of small plaque psoriasis in the Korean population, may filter out spurious signals while allowing for significant associations to emerge from a relatively low number of participants. By comparing Korean psoriasis participants in two geographically separated locations (Seoul, Korea vs. New York, NY, USA), it will also be interesting to understand the interactions between genetics and the environment that are still not well defined.
It is anticipated this study could lead to new understanding of the mechanisms involved in the spreading of psoriatic plaques and provide new insight into psoriasis pathogenesis.
- Conditions
- Psoriasis
- Being tested
- Skin biopsy and blood test
- Keywords
- Psoriasis, Korean, Healthy Volunteers
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsy and blood testProcedure or surgery
Analysis of histology and gene expression in affected and unaffected skin
| Study group | Role | What they receive |
|---|---|---|
| Biopsy and blood tests | Experimental | All subjects will undergo a skin biopsy and blood tests Receives: Procedure: Skin biopsy and blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients in Korea.
The primary outcome measure is the expression of IL-17 (the pivotal immune related molecule in psoriasis pathogenesis) in lesional psoriatic skin samples collected from patients in Korea. The expression of IL-17 is measured by Reverse transcription polymerase chain reaction (RT-PCR) and normalized to the expression of housekeeping gene (human acidic ribosomal protein [hARP]). The unit of outcome measure is log2(IL-17 expression/hARP expression).
Measured: 2 years
Secondary outcomes (1)
The secondary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients at The Rockefeller Hospital, New York.
The secondary outcome measure is the expression of IL-17 (the pivotal immune related molecule in psoriasis pathogenesis) in lesional psoriatic skin samples collected from patients at The Rockefeller Hospital, New York. The expression of IL-17 is measured by Reverse transcription polymerase chain reaction (RT-PCR) and normalized to the expression of housekeeping gene (human acidic ribosomal protein [hARP]). The unit of outcome measure is log2(IL-17 expression/hARP expression).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaehwan Kim, Rockefeller University
- Investigators
- Jaehwan Kim, MD PhD, Principal investigator, Rockefeller Univesrity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920906
- Sponsor's protocol ID
- JWK-0816
- Status last verified
- May 2016
- First submitted
- 6 Aug 2013
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Small and Large Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01920906
- Acronym / sponsor ID
- JWK-0816
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Korean, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Aug 2013 (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, debilitating skin disorder with an estimated prevalence of 2%. Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into plaques of varying sizes. Despite the great strides in the studies for psoriasis, it is still unclear why psoriatic skin lesions start with small macules and then spread peripherally.
To study peripheral spreading of psoriasis, investigators plan to study small plaque psoriasis in comparison to large plaque psoriasis in the Korean population. Large plaque psoriasis is the most common form of psoriasis, seen in approximately 90% of all psoriasis participants. Large psoriatic plaques are >5 cm in size and localize to the extensor aspects of the elbows, knees, scalp, and genital area. On the other hand, small plaque psoriasis is the common or typical form of psoriasis that occurs particularly in Korea and other Asian countries. Korean small plaque psoriasis, even when chronic, remains <2 cm in size and is widely distributed on the upper trunk and proximal extremities.
Investigators hypothesize that the expression of immune-related genes are different between small and large plaque psoriasis. The study of a genetically homogeneous cohort, characterized by the relatively high prevalence of small plaque psoriasis in the Korean population, may filter out spurious signals while allowing for significant associations to emerge from a relatively low number of participants.
By comparing small and large plaque psoriasis, it is expected this study could lead to new understandings of the mechanisms involved in spreading of psoriatic plaques and provide new insights into psoriasis development.
Detailed description
Psoriasis is a common chronic skin disorder with an estimated prevalence in populations of approximately 2%. Psoriatic skin lesions start with initial pinhead-sized macules and then coalesce into plaques of varying sizes in diameter from one to several centimeters.
Despite the great strides in the studies for psoriasis, it is still unclear why psoriatic skin lesions start with small macules and then spread peripherally. The occurrence of psoriasis is thought to be the pathological consequence of an exaggerated immune response as activated T cells, monocytes, neutrophils, and dendritic cells produce inflammatory cytokines that drive the additional recruitment of inflammatory cells, further elaboration of proinflammatory mediators, and the proliferation of keratinocytes. However, pathogenetic mechanism for peripheral spreading of psoriasis needs to be further elucidated.
To study peripheral spreading of psoriasis, investigators plan to study "small plaque psoriasis" and compare it to "large plaque psoriasis" in the Korean population.
Psoriasis vulgaris, so-called "large plaque psoriasis", is the most common form of psoriasis, seen in approximately 90% of all psoriasis patients. Red, scaly, symmetrically distributed plaques are usually larger than 5 cm in diameter and characteristically localized to the extensor aspects of the extremities, particularly the elbows and knees, along with scalp, lower lumbosacral, buttocks, and genital involvement. Approximately 1/4 to 1/3 of large plaque psoriasis participants have involvement of over 5% of their body surface area (BSA), and disease of this extent is frequently painful and physically and/or socially debilitating to a degree comparable with other chronic medical conditions.
On the other hand, "small plaque psoriasis" is the common or typical form of psoriasis that occurs in adults particularly in Korea and other Asian countries. Korean small plaque psoriasis, even when chronic, remain <2 cm in size and widely distributed on upper trunk and proximal extremities. Small plaque psoriasis is less severe than large plaque psoriasis, as it usually responds to phototherapy and more potent therapies are rarely needed.
It is also noteworthy that there are well-known human leukocyte antigen (HLA) differences in Caucasians in comparison with Asian participants with psoriasis, and a unique HLA haplotype has been described in Korean participants with psoriasis. Furthermore, an allele of an HLA-related gene, known as major histocompatibility complex I chain-related gene A, is known as a susceptibility marker in Korean and Chinese participants with psoriasis, but not in Spanish participants.
For a more comprehensive analysis of the difference between small and large plaque psoriasis, investigators plan to compare these two different types of psoriasis only in the Korean population. The study of a genetically homogeneous cohort, characterized by the relatively high prevalence of small plaque psoriasis in the Korean population, may filter out spurious signals while allowing for significant associations to emerge from a relatively low number of participants. By comparing Korean psoriasis participants in two geographically separated locations (Seoul, Korea vs. New York, NY, USA), it will also be interesting to understand the interactions between genetics and the environment that are still not well defined.
It is anticipated this study could lead to new understanding of the mechanisms involved in the spreading of psoriatic plaques and provide new insight into psoriasis pathogenesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy and blood tests | Experimental | Procedure: Skin biopsy and blood testAll subjects will undergo a skin biopsy and blood tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identified as Korean (defined as being Korean and both parents are Korean)
- History of small and/or large plaque psoriasis, for at least six months
- At least 18 years of age
- No treatment with topical steroids or vitamin D analogues for at least 2 weeks prior to entering the study.
- No treatment with systemic therapies, including phototherapy, acitretin, cyclosporine, methotrexate and biologics 4 weeks prior to entering the study. Among biologics, Ustekinumab (Stelara®) requires a longer washout period of 12 weeks.
Key exclusion criteria (8 listed)
- Erythrodermic, or pustular psoriasis as the sole or predominant form of psoriasis.
- Photosensitizing illnesses such as lupus, polymorphous light eruption, or any disease known to be worsened by UV light exposure.
- History of malignant melanoma.
- Pregnancy.
- Immunocompromising diseases such as HIV infection.
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 |
|---|---|---|
| Skin biopsy and blood testAnalysis of histology and gene expression in affected and unaffected skin | Procedure or surgery | Biopsy and blood tests |
Primary outcome
The primary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients in Korea.
Time frame: 2 years
The primary outcome measure is the expression of IL-17 (the pivotal immune related molecule in psoriasis pathogenesis) in lesional psoriatic skin samples collected from patients in Korea. The expression of IL-17 is measured by Reverse transcription polymerase chain reaction (RT-PCR) and normalized to the expression of housekeeping gene (human acidic ribosomal protein [hARP]). The unit of outcome measure is log2(IL-17 expression/hARP expression).
1 secondary outcome
The secondary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients at The Rockefeller Hospital, New York.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
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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.
Jaehwan Kim, MD PhD principal investigator
Rockefeller Univesrity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy and blood test in people with Psoriasis, run by Rockefeller University at 1 site in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 May 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the RT-PCR measurement of IL-17 in lesional psoriasis skin samples collected from patients in Korea. (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 6 May 2016.