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

NYU Langone Health

Status: Completed

Conditions: Psoriasis; Psoriatic Arthritis

Treatments: Dietary Supplement: PEVCO; Dietary Supplement: Dietary Supplement Capsules without Coconut Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03409211

17-00748

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Pso

Active Comparator group

Description:

with or without PsA

Treatment:

Dietary Supplement: Dietary Supplement Capsules without Coconut Oil

Dietary Supplement: PEVCO

Healthy Subjects

Active Comparator group

Description:

Without PsA

Treatment:

Dietary Supplement: Dietary Supplement Capsules without Coconut Oil

Dietary Supplement: PEVCO