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OpenTrials
Completed

NCT Number: NCT03409211

Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

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.

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Key information

Conditions

Psoriasis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriatic Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PEVCO

Dietary Supplement

All subjects will receive PEVCO for 6 more weeks.

Other names: Coconut Oil

Dietary Supplement Capsules without Coconut Oil

Dietary Supplement

All subjects will receive placebo (PBO) for 3 weeks

Primary outcomes

  1. Change in % of Treg Cells in Blood

    Time frame: 6 Weeks

    % change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.

Secondary outcomes

  1. Increase in Medium Chain Fatty Acids (MCFA) content in the stool

    Time frame: 12 Weeks

    Change in the amount of MCFA in stool

  2. Improvement in skin disease severity PASI scores 50

    Time frame: 12 Weeks

    indicating 50% reduction in psoriasis

  3. Improvement in skin disease severity PASI scores 75

    Time frame: 12 Weeks

    indicating 75% reduction in psoriasis

  4. Improvement in skin disease severity PASI scores 90

    Time frame: 12 Weeks

    indicating 90% reduction in psoriasis

  5. Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Acronym: PAMPPA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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