PsoriasisPAMPPANCT03409211
Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
A study testing PEVCO and Dietary Supplement Capsules without Coconut Oil in people with Psoriasis and Psoriatic Arthritis, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- What is being tested?
- PEVCO and Dietary Supplement Capsules without Coconut Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have an active [psoriatric plaque >2cm
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Psoriasis, Psoriatic Arthritis
- Being tested
- PEVCO, Dietary Supplement Capsules without Coconut Oil
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEVCODietary supplement
Also called Coconut Oil
All subjects will receive PEVCO for 6 more weeks.
Dietary Supplement Capsules without Coconut OilDietary supplement
All subjects will receive placebo (PBO) for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pso | Active comparator | with or without PsA Receives: Dietary Supplement: PEVCO; Dietary Supplement: Dietary Supplement Capsules without Coconut Oil |
| Healthy Subjects | Active comparator | Without PsA Receives: Dietary Supplement: PEVCO; Dietary Supplement: Dietary Supplement Capsules without Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in % of Treg Cells in Blood
% change in the expansion of regulatory T cells; demonstrate an increase in %Treg at 6 weeks.
Measured: 6 Weeks
Secondary outcomes (5)
Increase in Medium Chain Fatty Acids (MCFA) content in the stool
Change in the amount of MCFA in stool
Measured: 12 Weeks
Improvement in skin disease severity PASI scores 50
indicating 50% reduction in psoriasis
Measured: 12 Weeks
Improvement in skin disease severity PASI scores 75
indicating 75% reduction in psoriasis
Measured: 12 Weeks
Improvement in skin disease severity PASI scores 90
indicating 90% reduction in psoriasis
Measured: 12 Weeks
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
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start12 Dec 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Scher, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409211
- Sponsor's protocol ID
- 17-00748
- Acronym
- PAMPPA
- Status last verified
- Dec 2020
- First submitted
- 5 Jan 2018
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT03409211
- Acronym / sponsor ID
- PAMPPA / 17-00748
- Conditions
- Psoriasis, Psoriatic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pso | Active comparator | Dietary Supplement: PEVCO, Dietary Supplement: Dietary Supplement Capsules without Coconut Oilwith or without PsA |
| Healthy Subjects | Active comparator | Dietary Supplement: PEVCO, Dietary Supplement: Dietary Supplement Capsules without Coconut OilWithout PsA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have an active [psoriatric plaque >2cm
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEVCOAlso: Coconut OilAll subjects will receive PEVCO for 6 more weeks. | Dietary supplement | Healthy Subjects, Pso |
| Dietary Supplement Capsules without Coconut OilAll subjects will receive placebo (PBO) for 3 weeks | Dietary supplement | Healthy Subjects, Pso |
Primary outcome
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.
5 secondary outcomes
Increase in Medium Chain Fatty Acids (MCFA) content in the stool
Time frame: 12 Weeks
Improvement in skin disease severity PASI scores 50
Time frame: 12 Weeks
Improvement in skin disease severity PASI scores 75
Time frame: 12 Weeks
Improvement in skin disease severity PASI scores 90
Time frame: 12 Weeks
Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks.
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Scher, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEVCO and Dietary Supplement Capsules without Coconut Oil in people with Psoriasis and Psoriatic Arthritis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in % of Treg Cells in Blood (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.