Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis (PAMPPA)

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Dietary supplement: PEVCO; Dietary supplement: Dietary Supplement Capsules without Coconut Oil

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pso; with or without PsA	Dietary supplement: PEVCO; All subjects will receive PEVCO for 6 more weeks.; Other Names: Coconut Oil; Dietary supplement: Dietary Supplement Capsules without Coconut Oil; All subjects will receive placebo (PBO) for 3 weeks
Active Comparator: Healthy Subjects; Without PsA	Dietary supplement: PEVCO; All subjects will receive PEVCO for 6 more weeks.; Other Names: Coconut Oil; Dietary supplement: Dietary Supplement Capsules without Coconut Oil; All subjects will receive placebo (PBO) for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in % of Treg Cells in Blood	% change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in Medium Chain Fatty Acids (MCFA) content in the stool	Change in the amount of MCFA in stool	12 Weeks
Improvement in skin disease severity PASI scores 50	indicating 50% reduction in psoriasis	12 Weeks
Improvement in skin disease severity PASI scores 75	indicating 75% reduction in psoriasis	12 Weeks
Improvement in skin disease severity PASI scores 90	indicating 90% reduction in psoriasis	12 Weeks
Improvement in the tender joint/swollen joint (TJ/SJ) counts at 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	6 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: 17-00748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No