Back to resultsPatterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis (PAMPPA)
Primary Purpose
Psoriasis, Psoriatic Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEVCO
Dietary Supplement Capsules without Coconut Oil
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
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)
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pso
Healthy Subjects
Arm Description
with or without PsA
Without PsA
Outcomes
Primary Outcome Measures
Change in % of Treg Cells in Blood
% change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.
Secondary Outcome Measures
Increase in Medium Chain Fatty Acids (MCFA) content in the stool
Change in the amount of MCFA in stool
Improvement in skin disease severity PASI scores 50
indicating 50% reduction in psoriasis
Improvement in skin disease severity PASI scores 75
indicating 75% reduction in psoriasis
Improvement in skin disease severity PASI scores 90
indicating 90% reduction in psoriasis
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03409211
Brief Title
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
Acronym
PAMPPA
Official Title
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pso
Arm Type
Active Comparator
Arm Description
with or without PsA
Arm Title
Healthy Subjects
Arm Type
Active Comparator
Arm Description
Without PsA
Intervention Type
Dietary Supplement
Intervention Name(s)
PEVCO
Other Intervention Name(s)
Coconut Oil
Intervention Description
All subjects will receive PEVCO for 6 more weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement Capsules without Coconut Oil
Intervention Description
All subjects will receive placebo (PBO) for 3 weeks
Primary Outcome Measure Information:
Title
Change in % of Treg Cells in Blood
Description
% change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Increase in Medium Chain Fatty Acids (MCFA) content in the stool
Description
Change in the amount of MCFA in stool
Time Frame
12 Weeks
Title
Improvement in skin disease severity PASI scores 50
Description
indicating 50% reduction in psoriasis
Time Frame
12 Weeks
Title
Improvement in skin disease severity PASI scores 75
Description
indicating 75% reduction in psoriasis
Time Frame
12 Weeks
Title
Improvement in skin disease severity PASI scores 90
Description
indicating 90% reduction in psoriasis
Time Frame
12 Weeks
Title
Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks.
Description
To assess whether PEVCO 1000 mg four times daily for 6 weeks improves:
66/68 Tender-joint count
66/68 Swollen-joint count
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Scher, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
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