Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis
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|ClinicalTrials.gov Identifier: NCT02162472|
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : September 23, 2019
|Condition or disease|
This is a single-center, prospective, observational study that will recruit subjects from Northwestern University to examine the degree of improvement of psoriatic plaques during systemic therapy treatment. Thirty patients with a confirmed diagnosis of "active" psoriasis treated with a single systemic agent will be recruited from the Northwestern Medical Faculty Foundation Dermatology clinic. The study population will include 15 patients receiving adalimumab and 15 patients receiving methotrexate.
Eight visits will be completed for each subject: visit 0 (baseline) and visits 1-8 (week 2, 4, 6, 8, 12, 16 and 24). At the baseline visit, after informed consent is obtained, a capillaroscopic examination will be performed to assess for evidence of characteristic vascular alterations. If such changes are present, the remainder of the baseline visit will be completed. This includes gathering personal information (age, race, gender etc.), clinical history (time of first diagnosis, presentation site, treatment used, biopsy results if previously performed, etc.) and past medical history (including current and previous medications). At each of the subsequent visits (visit 1-8), any changes to medical history and/or medications will be obtained and recorded. At each of the eight visits, a dermatologic physical examination, including PASI and PGA scores will be performed.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Videocapillaroscopy Assessment During Systemic Agent Therapy in Patients With Psoriasis|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Subjects will receive adalimumab as standard of care for psoriasis
Subjects will receive methotrexate as standard of care for psoriasis
- Videocapillaroscopy assessment in psoriasis [ Time Frame: Week 0, 2, 4, 6, 8, 12, 16 and 24 ]The primary objective is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162472
|Contact: Beatrice Nardone, MD,PhDfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University, Department of Dermatology||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Beatrice Nardone, MD, PhD 312-503-5905 email@example.com|
|Principal Investigator: Joaquin Brieva, MD|
|Principal Investigator:||Joaquin Brieva, MD||Northwestern University|