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Behavioral Intervention
Mediterranean Diet for Psoriasis
N/A
Recruiting
Led By Neil Korman, MD
Research Sponsored by Neil Korman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
Have moderate to severe plaque psoriasis at Baseline as defined by BSA ≥5%, sPGA ≥3 (moderate to severe), or PASI ≥5
Must not have
History of positive HIV, or have congenital or acquired immunodeficiency
Having failed more than 3 systemic agents for treatment of psoriasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will last for about 10 weeks and participants will have 3 or 4 in-person visits. If participants are using prohibited psoriasis medications, there will be a two-week period where they
Who is the study for?
This trial is for individuals with psoriasis who are starting or already receiving Anti-IL-17 or Anti-IL-23 inhibitors. Participants must be willing to potentially change their diet and not use certain psoriasis medications like topical steroids or methotrexate during a two-week washout period.
What is being tested?
The study is testing if following a Mediterranean Diet can improve the symptoms of psoriasis compared to no dietary changes, in patients treated with biologic therapies targeting IL-17 or IL-23.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include typical reactions to changing one's diet such as digestive discomfort. The biologic treatments have their own side effects which are not part of this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic plaque psoriasis for over a year.
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I have moderate to severe plaque psoriasis.
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I am in good health with a BMI between 25 to 40.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have HIV or a condition that weakens my immune system.
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I have tried more than 3 treatments for psoriasis without success.
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My psoriasis is currently getting worse or is not stable.
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I have a history of chronic or recurring infections.
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I do not have skin or inflammatory conditions that could affect study results.
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I am allergic to certain medications for immune system diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: No Dietary InterventionActive Control1 Intervention
Participants in this arm will have no dietary intervention.
Group II: Mediterranean DietActive Control1 Intervention
Participants in this arm will follow the Mediterranean Diet.
Find a Location
Who is running the clinical trial?
Neil KormanLead Sponsor
Neil Korman, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
5 Previous Clinical Trials
122 Total Patients Enrolled
3 Trials studying Psoriasis
54 Patients Enrolled for Psoriasis
Jordan K Kahle, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center