Psoriasis Clinical Trial
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
Summary
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.
Eligibility Criteria
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)
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There is 1 Location for this study
New York New York, 10016, United States
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