- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537212
Study of the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
August 12, 2019 updated by: Jerry Bagel MD, Bagel, Jerry, M.D.
A Single-Center, Prospective, Single-Blinded, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
The association between psoriasis and obesity has been questioned by physicians for many years.
Studies have shown that the risk of having psoriasis is increased in people with a high body mass index, which is a measurement of obesity.
There have been case reports of remission of psoriasis after gastric bypass surgery.
Furthermore, other studies have shown that certain inflammatory diseases (such as rheumatoid arthritis) can be improved by dietary changes.
The purpose of this study is to assess whether a low carbohydrate or low fat diet can be helpful in the treatment of psoriasis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study involves the use of diet as a therapeutic agent in subjects with obesity and psoriasis who are eligible for and willing to undergo phototherapy.
Subjects undergoing phototherapy alone will be compared to subjects randomized to receive phototherapy and dietary modification with the goal of weight loss.
The primary objective is to determine the success rate of weight loss programs in the setting of psoriasis.
Secondary objectives include evaluating the effect of weight loss on efficacy of narrow band ultraviolet B phototherapy, and assessing the efficacy of lower carbohydrate and low fat diets in psoriatic patients.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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East Windsor, New Jersey, United States, 08520
- Jerry Bagel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age greater than 18
- PASI score greater than 10
- BMI greater than 25
- Subjects must be willing and eligible to undergo phototherapy and
- Willing to stop all other psoriasis therapies
Exclusion Criteria:
- History of failure to respond to NB-UVB in the past.
- Presence of predominantly guttate, erythrodermic, or pustular psoriasis or any skin condition that would interfere with evaluation of effect of study. intervention .
- Treatment with systemic antibiotics, topical steroids (except to groin and face), topical Vitamin A or D analogs, or ultraviolet B therapy within 2 weeks of study initiation.
- Use or oral or parenteral corticosteroids.
- Use of appetite suppressants or other medications know to affect appetite or weight.
- Treatment with biologic therapy in the past 3 months.
- History of cutaneous malignancy, including any squamous cell carcinoma or melanoma or more than two basal cell carcinomas, current actinic keratoses or atypical moles.
- Evidence of photosensitivity disorder (e.g.polymorphous light eruption.
- Use of other investigational drugs, any systemic psoriasis therapy, psoralen plus ultraviolet A therapy (PUVA) within 4 weeks of study drug initiation.
- Subjects who are currently achieving good clinical control of their psoriasis on their current therapy.
- Concomitant serious illness or medical condition that may interfere with participation in the study including renal failure, hepatic failure or systemic lupus erythematosus.
- Subject currently enrolled in another investigational device or drug trial(s), or that may compromise the safety of data collection.
- Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
- Subject known to be pregnant or breastfeeding.
- Evidence of skin conditions (e.g.,eczema) other than psoriasis that would interfere with study-related evaluations of psoriasis.
- History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol.
- History of non-compliance with other therapies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet."
|
Subjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss.
Subjects also receive a copy of "The South Beach Diet."
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Active Comparator: 2
Subjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet."
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Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss.
Subjects also receive a copy of "The Ornish Diet" book.
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Sham Comparator: 3
Subjects will receive phototherapy alone, without dietary counselling.
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This group will receive phototherapy alone.
They will not be counselled or give literature on a particular diet.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PASI improvement
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
which group's PASI did better
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jerry Bagel, M.D., Psoriasis Treatment Center of Central New Jersey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
September 28, 2007
First Submitted That Met QC Criteria
September 28, 2007
First Posted (Estimate)
October 1, 2007
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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