Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/26/2018 |
Start Date: | December 12, 2017 |
End Date: | December 2020 |
Contact: | Luz Alvarado |
Email: | Luz.Alvarado@nyumc.org |
Phone: | 646-501-7400 |
This is a proof-of-principle, placebo-controlled, open label study to assess the improvement
in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients
with PsO (subjects may or may not have PsA) , who have active disease and are not currently
receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy
subjects.
The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3
weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be
used during this period.
in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients
with PsO (subjects may or may not have PsA) , who have active disease and are not currently
receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy
subjects.
The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3
weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be
used during this period.
Inclusion Criteria:
- Have an active [psoriatric plaque >2cm
Exclusion Criteria:
- History of sensitivity to study compound or any of their excipients
- Previous intolerance to PEVCO or related compounds
- Current (within 3 months of screening) treatment with DMARDs
- Current (within 3 months of screening) treatment with biologic therapies (including
but limited to anti-TNF,anti-IL-17, anti-IL-12/23)
- Current antibiotic treatment (within 3 months of screening)
- current consumption of probiotics (within 3 months of screening)
- Severe hepatic impairment (eg, ac-sites and/or clinical signs of coagulopathy)
- Renal failure (eGFR ,30 or require dialysis) by history
- History of other autoimmune or inflammatory skin disease
- Current immunodeficiency state (cancer, HIV, others)
- Current immunodeficiency state (cancer, HIV, Other)
- Concern for inability of the patient to comply with study procedure, and or follow up
(alcohol or drug abuse)
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Jose U Scher, MD
Phone: 646-501-7400
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