Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/15/2019 |
| Start Date: | July 2015 |
| End Date: | July 2019 |
| Contact: | Beatrice Nardone, MD,PhD |
| Email: | b-nardone@northwestern.edu |
| Phone: | 312-503-5905 |
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.
and reliable method to assess psoriasis severity and to document improvement during treatment
by measuring changes in vascular features.
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.
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.
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.
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Joaquin Brieva, MD
Phone: 312-503-5905
Click here to add this to my saved trials
