Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

Not Applicable

Completed

• Conditions: Psoriasis; Psoriatic Arthritis
• Interventions: Dietary Supplement: PEVCO; Dietary Supplement: Dietary Supplement Capsules without Coconut Oil

• Registration Number: NCT03409211
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-12
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Have an active [psoriatric plaque >2cm

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pso	PEVCO	with or without PsA
Healthy Subjects	Dietary Supplement Capsules without Coconut Oil	Without PsA
Pso	Dietary Supplement Capsules without Coconut Oil	with or without PsA
Healthy Subjects	PEVCO	Without PsA

Primary Outcome Measures

Name	Time	Method
Change in % of Treg Cells in Blood	6 Weeks	% change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Increase in Medium Chain Fatty Acids (MCFA) content in the stool	12 Weeks	Change in the amount of MCFA in stool
Improvement in skin disease severity PASI scores 50	12 Weeks	indicating 50% reduction in psoriasis
Improvement in skin disease severity PASI scores 75	12 Weeks	indicating 75% reduction in psoriasis
Improvement in skin disease severity PASI scores 90	12 Weeks	indicating 90% reduction in psoriasis
Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks.	6 Weeks	To assess whether PEVCO 1000 mg four times daily for 6 weeks improves: * 66/68 Tender-joint count; * 66/68 Swollen-joint count

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States