Clincosm LogoSign in Get a demo

PAMPPA: Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03409211
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
21.6
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: PEVCO
  • Dietary Supplement: Dietary Supplement Capsules without Coconut Oil
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
Actual Study Start Date :
Dec 12, 2017
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Increase in Medium Chain Fatty Acids (MCFA) content in the stool [12 Weeks]

      Change in the amount of MCFA in stool

    2. Improvement in skin disease severity PASI scores 50 [12 Weeks]

      indicating 50% reduction in psoriasis

    3. Improvement in skin disease severity PASI scores 75 [12 Weeks]

      indicating 75% reduction in psoriasis

    4. Improvement in skin disease severity PASI scores 90 [12 Weeks]

      indicating 90% reduction in psoriasis

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University School of Medicine New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Jose Scher, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03409211
    Other Study ID Numbers:
    • 17-00748
    First Posted:
    Jan 24, 2018
    Last Update Posted:
    Dec 2, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Psoriatic
    Psoriasis

    Study Results

    No Results Posted as of Dec 2, 2020