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Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02162472
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Joaquin Brieva, MD
Principal Investigator Affiliation Northwestern University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Additional Details

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.

Arms & Interventions

Arms

: Adalimumab

Subjects will receive adalimumab as standard of care for psoriasis

: Methotrexate

Subjects will receive methotrexate as standard of care for psoriasis

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Recruiting

Address

Northwestern University, Department of Dermatology

Chicago, Illinois, 60611

Site Contact

Beatrice Nardone, MD, PhD

b-nardone@northwestern.edu

312-503-5905

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