Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis

Videocapillaroscopy Assessment During Systemic Agent Therapy in Patients With Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Videocapillaroscopy assessment in psoriasis	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.	Week 0, 2, 4, 6, 8, 12, 16 and 24

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: AbbVie
• Investigators: Principal Investigator: Joaquin Brieva, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: videocapillaroscopy, psoriasis, systemic agent
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: STU78102