Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis

NCT ID: NCT03409211

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Psoriasis Psoriatic Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pso

with or without PsA

Group Type ACTIVE_COMPARATOR

PEVCO

Intervention Type DIETARY_SUPPLEMENT

All subjects will receive PEVCO for 6 more weeks.

Dietary Supplement Capsules without Coconut Oil

Intervention Type DIETARY_SUPPLEMENT

All subjects will receive placebo (PBO) for 3 weeks

Healthy Subjects

Without PsA

Group Type ACTIVE_COMPARATOR

PEVCO

Intervention Type DIETARY_SUPPLEMENT

All subjects will receive PEVCO for 6 more weeks.

Dietary Supplement Capsules without Coconut Oil

Intervention Type DIETARY_SUPPLEMENT

All subjects will receive placebo (PBO) for 3 weeks

Interventions

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PEVCO

All subjects will receive PEVCO for 6 more weeks.

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement Capsules without Coconut Oil

All subjects will receive placebo (PBO) for 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Coconut Oil

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Scher, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-00748

Identifier Type: -

Identifier Source: org_study_id