Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis

NCT02162472 | Completed DMC

• 1 other identifier: STU78102
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

videocapillaroscopy, psoriasis, systemic agent

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Adalimumab

Subjects will receive adalimumab as standard of care for psoriasis

Methotrexate

Subjects will receive methotrexate as standard of care for psoriasis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are unable to understand the protocol or give informed consent.

Sponsors & Collaborators

• Northwestern University: lead
• AbbVie: collaborator

Study Sites (1)

Northwestern University, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joaquin Brieva, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: July 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

US (1)