PsoriasisNCT01122095
Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis
An observational study of Psoriasis and Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
Hypothesis 1: Patients with psoriasis will have clinical and laboratory assessments differing from control patients. Hypothesis 2: Patients with psoriasis will have laboratory alterations that correlate with other clinical characteristics of their psoriasis. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Obesity, Cardiovascular Risk
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2011
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: case subjects, male or female, with typical psoriasis, with or without arthritis, ages 0 to 18 years of age and of all races and ethnicities control subjects, male or female, normal, health, non-soriatic subjects, 0 to 18 years of age.
Who may be able to join
- Subjects of any race or ethnicity who meet all of the following criteria are eligible for enrollment into the study:
- The subject has a diagnosis of typical psoriasis, with or without arthritis, based on the clinical evaluation by an investigator or a prior diagnosis by a pediatric dermatologist
- Persons residing in the US.
- Subjects 0 to 18 years of age.
- Subjects/Guardians willing and able to comply with the requirements of the study.
- Subjects/Guardians willing and able to give informed consent.
- The subject is in general good health in the opinion of the investigator.
Who cannot join
- Over 18 years of age.
- Subject has had a diagnosis of congenital heart disease.
- Subject has had any cardiac catheterizations or surgeries.
- Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
- Subjects determined to have atypical psoriasis or isolated palmoplantar psoriasis.
- Subject diagnosed with any other systemic inflammatory disease including atopic dermatitis, severe acne vulgaris, inflammatory bowel disease, juvenile idiopathic arthritis, connective tissue disease and other similar conditions.
Show all 26Show fewer
- Having autoimmune or immunodeficiency disease.
- Presence of active systemic fungal, bacterial, or viral infections.
- Presence of active systemic malignancy.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Inability or unwillingness of a participant to give written informed consent.
- Control Inclusion Criteria:
- Age up to 18 years.
- Ability and willingness to provide informed consent.
- Control Exclusion Criteria:
- Over 18 years of age.
- Subject has had a diagnosis of congenital heart disease.
- Subject has had any cardiac catheterizations or surgeries.
- Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
- Subjects determined to have psoriasis of any type or a family history (first degree relative) with psoriasis.
- Subject diagnosed with any other systemic inflammatory disease including atopic dermatitis, severe acne vulgaris, inflammatory bowel disease, juvenile idiopathic arthritis, connective tissue disease and other similar conditions.
- Having autoimmune or immunodeficiency disease.
- Presence of active systemic fungal, bacterial, or viral infections.
- Presence of active systemic malignancy.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Inability or unwillingness of a participant to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital Dermatolgoy
San Diego, California, 92123
Donna Pascual, LVN, 858-576-1700 ext. 4295, dpascual@rchsd.org
Ann Funk, RN, CCRC, 858-576-1700 ext. 4295, afunk@rchsd.org
About this study
Hypothesis 1: Patients with psoriasis will have clinical and laboratory assessments differing from control patients.
Hypothesis 2: Patients with psoriasis will have laboratory alterations that correlate with other clinical characteristics of their psoriasis.
Read the detailed description
Psoriasis was initially considered an inflammatory condition primarily of the skin. However, advances in medical knowledge have allowed insight into the wide-ranging systemic effects of long-term uncontrolled inflammation, thus shifting the concept of psoriasis from an inflammatory disease restricted to the skin to a systemic process. Adults w/ psoriasis have higher rates of obesity, hypertension, diabetes, hyperlipidemia and smoking and the prevalence of each risk factor increases as the extent of psoriasis increases.1 It is uncertain if any of this relates to a behavioral reaction to having psoriasis or as a separate part of the disease process. Inflammation has a role in the pathogenesis of cardiovascular disease most noted by multiple observational studies of psoriasis patients which demonstrate an increased risk of arterial or venous events, notably myocardial infarction, cerebrovascular events, pulmonary emboli, cardiovascular death or mortality overall. Specifically, Gelfand et. al. show an increased relative risk for myocardial infarction and an increased hazard ratio for mortality in patients with severe psoriasis, but most notably, show highest risk in younger adult patients. There is a paucity of data on risks with psoriasis in the pediatric and adolescent age group.
- Conditions
- Psoriasis, Obesity, Cardiovascular Risk, Inflammation
- Keywords
- Psoriasis, Cardiovascular risk
- Medical subject headings
- Psoriasis, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease | |
| Control patient | Age matched, without psoriasis or significant inflammatory disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity risk assessment
Body Mass Index; C-reactive protein (CRP)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startApr 2010
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Lawrence F. Eichenfield, MD, Principal investigator, University of Calfornia, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122095
- Sponsor's protocol ID
- 20080414
- Status last verified
- Apr 2010
- First submitted
- 27 Apr 2010
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB , Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol 2006;55:829-35. 2. Gelfand J, Neimann A, Shin D et al. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296:1735-1741. 3. Gelfand J, Troxel B, Lewis J et al. The risk of mortality in patients with psoriasis: Results from a population-based study. Arch Dermatol. 2007;143(12):1493-1499 4. Kelishadi R, Ardalan G, Gheiratmand R, Adeli K, Delavari A, and Majdzadeh R et al. Pediatric metabolic syndrome and associated anthropometric indices: the CASPIAN study. Acta Paediatrica, 2006. 95: 1625-1634. 5. Goodman E, Dolan L, Morrison J and Daniels S. Factor Analysis of Clustered Cardiovascular Risks in Adolescence. Circulation 2005; 111: 1970-1977. 6. Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular Risk Factors and the Metabolic Syndrome in Pediatric Nonalcoholic Fatty Liver Disease. Circulation. 2008 June. 118:277-283.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Evaluation of Biological Markers of Cardiovascular Disease in Children and Adolescents With Psoriasis
- ClinicalTrials.gov ID
- NCT01122095
- Acronym / sponsor ID
- 20080414
- Conditions
- Psoriasis, Obesity, Cardiovascular Risk, Inflammation
- Keywords
- Psoriasis, Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Apr 2010
- Study completion
- Apr 2011 (estimated)
- First posted
- 12 May 2010 (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.
Hypothesis 1: Patients with psoriasis will have clinical and laboratory assessments differing from control patients.
Hypothesis 2: Patients with psoriasis will have laboratory alterations that correlate with other clinical characteristics of their psoriasis.
Detailed description
Psoriasis was initially considered an inflammatory condition primarily of the skin. However, advances in medical knowledge have allowed insight into the wide-ranging systemic effects of long-term uncontrolled inflammation, thus shifting the concept of psoriasis from an inflammatory disease restricted to the skin to a systemic process. Adults w/ psoriasis have higher rates of obesity, hypertension, diabetes, hyperlipidemia and smoking and the prevalence of each risk factor increases as the extent of psoriasis increases.1 It is uncertain if any of this relates to a behavioral reaction to having psoriasis or as a separate part of the disease process. Inflammation has a role in the pathogenesis of cardiovascular disease most noted by multiple observational studies of psoriasis patients which demonstrate an increased risk of arterial or venous events, notably myocardial infarction, cerebrovascular events, pulmonary emboli, cardiovascular death or mortality overall. Specifically, Gelfand et. al. show an increased relative risk for myocardial infarction and an increased hazard ratio for mortality in patients with severe psoriasis, but most notably, show highest risk in younger adult patients. There is a paucity of data on risks with psoriasis in the pediatric and adolescent age group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | –Children with psoriasis Age matched controls without psoriasis or other significant inflammatory disease |
| Control patient | – | –Age matched, without psoriasis or significant inflammatory disease |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- case subjects, male or female, with typical psoriasis, with or without arthritis, ages 0 to 18 years of age and of all races and ethnicities control subjects, male or female, normal, health, non-soriatic subjects, 0 to 18 years of age.
Key inclusion criteria (7 listed)
- Subjects of any race or ethnicity who meet all of the following criteria are eligible for enrollment into the study:
- The subject has a diagnosis of typical psoriasis, with or without arthritis, based on the clinical evaluation by an investigator or a prior diagnosis by a pediatric dermatologist
- Persons residing in the US.
- Subjects 0 to 18 years of age.
- Subjects/Guardians willing and able to comply with the requirements of the study.
Key exclusion criteria (26 listed)
- Over 18 years of age.
- Subject has had a diagnosis of congenital heart disease.
- Subject has had any cardiac catheterizations or surgeries.
- Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
- Subjects determined to have atypical psoriasis or isolated palmoplantar psoriasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obesity risk assessment
Time frame: 6 months
Body Mass Index; C-reactive protein (CRP)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2010.
- Background1. Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB , Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol 2006;55:829-35. 2. Gelfand J, Neimann A, Shin D et al. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296:1735-1741. 3. Gelfand J, Troxel B, Lewis J et al. The risk of mortality in patients with psoriasis: Results from a population-based study. Arch Dermatol. 2007;143(12):1493-1499 4. Kelishadi R, Ardalan G, Gheiratmand R, Adeli K, Delavari A, and Majdzadeh R et al. Pediatric metabolic syndrome and associated anthropometric indices: the CASPIAN study. Acta Paediatrica, 2006. 95: 1625-1634. 5. Goodman E, Dolan L, Morrison J and Daniels S. Factor Analysis of Clustered Cardiovascular Risks in Adolescence. Circulation 2005; 111: 1970-1977. 6. Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular Risk Factors and the Metabolic Syndrome in Pediatric Nonalcoholic Fatty Liver Disease. Circulation. 2008 June. 118:277-283.
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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.
Lawrence F. Eichenfield, MD principal investigator
University of Calfornia, San Diego
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 and Obesity, run by University of California, San Diego 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 7 inclusion and 26 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 31 May 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lawrence F. Eichenfield, MD (858-966-1700, leichenfield@rchsd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity risk assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122095, which also lists 1 linked publication.
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 31 May 2010.