Reviewed by Michael Gill, B. Sc.
Image of The Ohio State University Wexner Medical Center in Columbus, United States.
Phase-Based Progress Estimates
1
Effectiveness
1
Safety

Intermittent Fasting Groupfor Psoriatic Arthritis

18+
All Sexes
Our study aims to determine whether intermittent fasting (IMF) is a valid method to improve psoriasis and psoriatic arthritis (PsA) disease severity and quality of life. There is a call for dermatologists to participate in the education and support for patients with psoriasis regarding their weight management, and the impact that other lifestyle modifications can have on their skin disease. Dietary interventions are low cost and safe ways to potentially decrease disease severity, reduce medical comorbidities, and improve effects of standard psoriasis therapies. Based on our findings, the investigators hope to provide a framework for further investigation into the role of IMF and other diets in psoriasis and to contribute to the establishment of well-defined dietary recommendations. Additionally, the investigators hope to further identify which patients would benefit most from these interventions. Patients within OSU Dermatology with psoriasis and/or psoriatic arthritis will be enrolled in a dietary intervention for a 24-week period. A prospective, single-blind parallel group randomized control trial will include an IMF dietary intervention group and a standard routine diet group for a duration of 24 weeks. After the initial 12 weeks of the dietary intervention, patients will be followed for an additional 12 weeks to assess changes in their disease state and quality of life after returning to their initial dietary routines. In total, the study will be 24 weeks. Baseline assessment will consist of standard psoriasis and PsA clinical parameters; evaluation will be performed by a blinded physician. These parameters will be reassessed every 4 weeks via video visit for the three month duration of the study, and then again at the 24-week conclusion of the study. In addition, each visit will assess patient-reported outcomes using dermatology-specific quality of life indices. Biometric measurements of weight, height, BMI, and waist-to-hip ratio will be recorded at baseline and all subsequent visits. Dietary adherence will be assessed by virtual check-in visits, and dietary guidance will be provided and reviewed at each visit by the research coordinator. A physician or the research coordinator will be available for questions between times of data collection. The primary outcome measure will be feasibility of a larger study, which will be determined at the initial 12-week timepoint. This data is vital to determine effect size and dropout frequency for future studies. Secondary outcomes will include changes in clinical indices, biometric measurements, and quality of life indices at 12 weeks after randomization and at the end of the 24-week study. Achievement of a 5% weight reduction at 12 weeks, and a 10-15% weight reduction at 24 weeks will be additional secondary endpoints. Data for each patient will be stored in a password-protected and encrypted REDCAP database on a secure OSU server. Each patient will receive a random numerical identity in the database which their data points will be associated with. Data access is role-based and limited to PI, research coordinator, statistician, and support staff.
Recruiting
Has No Placebo
The Ohio State University Wexner Medical CenterBenjamin H Kaffenberger, MD, MS
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Recently Completed Studies with FDA Approved Treatments for Psoriasis
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Arcutis Biotherapeutics, Inc.
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Andrew Alexis, MD

What Are Psoriasis Clinical Trials?

Clinical trials aim to find new, more tolerable treatments for patients with Psoriasis.

Scientists believe the autoimmune system attacks healthy skin cells and causes affected skin to grow faster than healthy skin. Psoriasis results from a genetic predisposition to the disease and environmental factors.

Clinical trials involve developing and testing treatments for topical application to alleviate symptoms and oral or injectable medication to treat medical causes and prevent flare-ups or worsening of the condition.

Because Psoriasis is a visible condition, measuring the outcome of medical intervention is relatively straightforward. The preferred method to assess the severity of the condition is the Psoriasis Area and Severity Index (PASI). The PASI index grades redness, scaliness, and thickness of lesions in ratings of 1 – 4.

A baseline is established for a clinical trial to be viable, and the treatment should provide a 75% improvement on the initial PASI rating.

There are other ways to monitor the severity of the disease:

  • National Psoriasis Foundation Psoriasis Score (NPF-PS)
  • Physician Global Static Assessment (PSGA)
  • Overall Lesion Assessment (OLA)

Each assessment considers BSA, the body surface area affected, and QOL, quality of life measurement.

Why Is Psoriasis Being Studied Through Clinical Trials?

As an autoimmune disease, Psoriasis results in skin cells growing faster than usual and creating lesions on the body. The lesions become thick and inflamed, resulting in itchy, scaly patches growing on the body. Symptoms range from mild to severe and, in extreme cases, have a debilitating effect.

There are 6 Psoriasis, Plaque Psoriasis, Guttate Psoriasis, Inverse Psoriasis, Pustular Psoriasis, and Erythrodermic Psoriasis. Each variant manifests on the skin and causes mild to severe discomfort.

What Are The Types of Treatments Available For Psoriasis?

Treatment for Psoriasis is divided into topical, oral, and injectables. Patients may use a combination of treatment types based on the most effective relief from symptoms and the spread of the disease.

  • Topical creams - steroid ointments, vitamin D analogs, emollients, and coal tar
  • Oral immune suppressants - Cyclosporine, Methotrexate and Acetretin
  • Oral Retanoid Medication – Acitretin
  • Biologic injectables - Etanercept, Adalimumab and Stelara

What Are Some Recent Breakthrough Clinical Trials For Psoriasis?

2022: Sotyktu (Deucravacitinib) is one of the new-generation oral medications for Psoriasis and is FDA-approved. After a 112-week treatment regime, patients showed an 82.4% improvement, of which 52.5% reached a PASI rating of 90, indicating little to no symptoms.

2022: VTAMA (Tapinarof Cream) 1% is a non-steroidal cream used to treat mild to severe Psoriasis in adults. Patients using VTAMA showed, on average, a 75% improvement compared to their baseline symptoms. VTAMA is safe to use in all areas of the body.

Who Are Some Of The Key Opinion Leaders In Psoriasis Clinical Trial Research?

Mark G Lebwohl, MD Dermatology, Internal Medicine, is the Dean of Clinical Therapeutics at the Kimberly and Eric J Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. He has chaired many synopses on Psoriasis Research and written several books on the topic of Psoriasis.

Dr. Kim A Papp, MD, Ph.D., FRCPC, has 25 years of experience as a Principle Investigator and has conducted many trials in Psoriasis. He is a consultant to 40 pharmaceutical companies and the author of 800 publications.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.