PsoriasisNCT02162472
Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis
An observational study of Psoriasis, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Those who do not fit the inclusion criteria.
- Subjects who are unable to understand the protocol or give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis
- Keywords
- videocapillaroscopy, psoriasis, systemic agent
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Subjects will receive adalimumab as standard of care for psoriasis | |
| Methotrexate | Subjects will receive methotrexate as standard of care for psoriasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, 2, 4, 6, 8, 12, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJul 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Joaquin Brieva, Northwestern University
- Investigators
- Joaquin Brieva, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162472
- Sponsor's protocol ID
- STU78102
- Status last verified
- Jan 2022
- First submitted
- 10 Jun 2014
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videocapillaroscopy Assessment During Systemic Agent Therapy in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT02162472
- Acronym / sponsor ID
- STU78102
- Conditions
- Psoriasis
- Keywords
- videocapillaroscopy, psoriasis, systemic agent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- Jul 2015
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | – | –Subjects will receive adalimumab as standard of care for psoriasis |
| Methotrexate | – | –Subjects will receive methotrexate as standard of care for psoriasis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Those who do not fit the inclusion criteria.
- Subjects who are unable to understand the protocol or give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Related trials for Psoriasis
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Active, not recruitingPhase 3
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
Psoriatic Arthritis (PsA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquin Brieva, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Videocapillaroscopy assessment in psoriasis (time frame: Week 0, 2, 4, 6, 8, 12, 16 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.