Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT01122095
Eligibility Criteria:
Inclusion Criteria:
Subjects of any race or ethnicity who meet all of the following criteria are eligible for enrollment into the study:
1. 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
2. Persons residing in the US.
3. Subjects 0 to 18 years of age.
4. Subjects/Guardians willing and able to comply with the requirements of the study.
5. Subjects/Guardians willing and able to give informed consent.
6. The subject is in general good health in the opinion of the investigator.
Exclusion Criteria:
1. Over 18 years of age.
2. Subject has had a diagnosis of congenital heart disease.
3. Subject has had any cardiac catheterizations or surgeries.
4. Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
5. Subjects determined to have atypical psoriasis or isolated palmoplantar psoriasis.
6. 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.
7. Having autoimmune or immunodeficiency disease.
8. Presence of active systemic fungal, bacterial, or viral infections.
9. Presence of active systemic malignancy.
10. 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.
11. Inability or unwillingness of a participant to give written informed consent.
Control Inclusion Criteria:
1. Age up to 18 years.
2. Ability and willingness to provide informed consent.
Control Exclusion Criteria:
1. Over 18 years of age.
2. Subject has had a diagnosis of congenital heart disease.
3. Subject has had any cardiac catheterizations or surgeries.
4. Subject has taken any cardiac medications (calcium channel blockers, beta blockers, vasotropic medicines) within the past 2 years.
5. Subjects determined to have psoriasis of any type or a family history (first degree relative) with psoriasis.
6. 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.
7. Having autoimmune or immunodeficiency disease.
8. Presence of active systemic fungal, bacterial, or viral infections.
9. Presence of active systemic malignancy.
10. 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.
11. Inability or unwillingness of a participant to give written informed consent.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01122095
Study Brief:
Protocol Section:
NCT01122095