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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 : March 13, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Joaquin Brieva, Northwestern University

Brief Summary:
The aim of this study 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.

Condition or disease
Psoriasis

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Videocapillaroscopy Assessment During Systemic Agent Therapy in Patients With Psoriasis
Study Start Date : July 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
Adalimumab
Subjects will receive adalimumab as standard of care for psoriasis
Methotrexate
Subjects will receive methotrexate as standard of care for psoriasis



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Subjects with a clinical diagnosis of chronic active plaque psoriasis
  • Subjects eligible for systemic monotherapy (oral or biologic agents).
  • Subjects with evidence of characteristic vascular alterations on capillaroscopic examination.
  • Subjects who are able to complete the study visits and procedures, including completion of the DLQI questionnaire.
  • Subjects who are willing to have standardized digital photographs taken of 2 different target plaque lesions on the extremities.
  • Subjects who are willing to have videocapillaroscopic photographs taken of 2 different target plaque lesions as well as of 2 areas of uninvolved skin on the extremities.
  • Subjects who have had a "4 week" washout period if they have recently changed systemic psoriatic therapy.

Exclusion Criteria:

  • Those who do not fit the inclusion criteria.
  • Subjects who are unable to understand the protocol or give informed consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Beatrice Nardone, MD,PhD 312-503-5905 b-nardone@northwestern.edu

Locations
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United States, Illinois
Northwestern University, Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
Contact: Beatrice Nardone, MD, PhD    312-503-5905    b-nardone@northwestern.edu   
Principal Investigator: Joaquin Brieva, MD         
Sponsors and Collaborators
Northwestern University
AbbVie
Investigators
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Principal Investigator: Joaquin Brieva, MD Northwestern University

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Responsible Party: Joaquin Brieva, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02162472     History of Changes
Other Study ID Numbers: STU78102
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Joaquin Brieva, Northwestern University:
videocapillaroscopy, psoriasis, systemic agent
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents