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 Plaque Psoriasis
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ADX-629
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Aldeyra Therapeutics, Inc.
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Andrew Alexis, MD

What Are Plaque Psoriasis Clinical Trials?

It is an autoimmune health condition. Plaque psoriasis is characterized by raised and dry patches of skin covered with silver and gray scales. The color of these patches varies depending on the patient’s skin color. These can appear in a few patches of plaques or sometimes even many. Once cleared, the skin color may be affected temporarily, becoming darker or lighter than before. The dry patches caused by plaque psoriasis may occur on the knees, scalp, elbows, and lower back. The condition appears symmetrically, affecting the same areas of the patient’s body on the left or right side. Moreover, it is often accompanied by nail psoriasis. The causes of plaque psoriasis include variables such as infections, stress, alcohol use, medication, or skin injury.

Plaque psoriasis clinical trials are studies that help develop a better understanding of the condition. Researchers also use them to determine prevention techniques and innovative treatments to manage the condition successfully.

Why Is Plaque Psoriasis Being Studied Through Clinical Trials?

Among all other types, plaque psoriasis is the most common. Statistics show that over eight million individuals in the United States of America have psoriasis. And nearly 80% to 90% of people with psoriasis suffer from plaque psoriasis. Similarly, approximately 125 million individuals, roughly 3 percent of the world’s total population, have some form of psoriasis.

Although the condition is common and millions suffer from it in the US and worldwide, there is still no cure for plaque psoriasis. Hence, plaque psoriasis is being studied through clinical trials even today. These studies help researchers experiment and evaluate the efficacy of new treatments and determine the best one. Furthermore, clinical trials are required to discover the actual cause of the condition and the proper cure. At present, the disease is only manageable but not curable.

What Are the Types of Treatments Available for Plaque Psoriasis?

Some of the best ways to manage plaque psoriasis are to improve your lifestyle such as:

  • Take baths daily
  • Avoid smoking
  • Identify triggers like stress
  • Keep skin moisturized

In the case of moderate and severe cases, patients may be advised of light therapy. Sometimes treatments like steroid creams and coal tar may be effective.

What Are Some Recent Breakthrough Clinical Trials for Plaque Psoriasis?

2015: Subjective stress reactivity in psoriasis- The study included 101 participants with plaque psoriasis. They were questioned about stress in their lives. The study aimed to determine whether psoriasis patients reported a link between distress and stress reactors or not. It was concluded that approximately 64 percent of the people reported subjective association. The study presents crucial opportunities for researchers to determine how patients can benefit from psychological exploration and alleviate their condition.

2022: Bimekizumab Safety in Patients with Moderate to Severe Plaque Psoriasis-The study was conducted to evaluate Bimekizumab two year safety profile with patients suffering from moderate and severe psoriasis. The results revealed that Bimekizumab was tolerated well by patients; safety is still a question mark because of the increased mild and moderate cases of oral candidiasis.

Who Are Some Key Opinion Leaders/Researchers/Institutions Conducting Plaque Psoriasis Clinical Trial Research?

National Psoriasis Foundation

The organization is dedicated to helping patients get the best treatment they require while facilitating research to discover a cure for plaque psoriasis.

American Academy of Dermatology

It is committed to providing the best source of information and knowledge and advancing research on psoriasis with authenticity. AAD is the largest of all dermatologic associations advocating the highest industry standard for clinical practice.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 29th, 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.

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