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A Single-Center, Prospective, Single-Blinded, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
This study is currently Recruiting
September 2007 By Bagel, Jerry, M.D.
First Recieved on September 28, 2007
Last Updated on September 28, 2007
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.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet."
Subjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet."
Subjects will receive phototherapy alone, without dietary counselling.
|Other: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."
|Other:The Ornish Diet|
Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of "The Ornish Diet" book.
This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Age greater than 18
2. PASI score greater than 10
3. BMI greater than 25
4. Subjects must be willing and eligible to undergo phototherapy and
5. Willing to stop all other psoriasis therapies
1. History of failure to respond to NB-UVB in the past.
2. Presence of predominantly guttate, erythrodermic, or pustular psoriasis or any skin
condition that would interfere with evaluation of effect of study. intervention .
3. 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
4. Use or oral or parenteral corticosteroids.
5. Use of appetite suppressants or other medications know to affect appetite or weight.
6. Treatment with biologic therapy in the past 3 months.
7. History of cutaneous malignancy, including any squamous cell carcinoma or melanoma or
more than two basal cell carcinomas, current actinic keratoses or atypical moles.
8. Evidence of photosensitivity disorder (e.g.polymorphous light eruption.
9. Use of other investigational drugs, any systemic psoriasis therapy, psoralen plus
ultraviolet A therapy (PUVA) within 4 weeks of study drug initiation.
10. Subjects who are currently achieving good clinical control of their psoriasis on
their current therapy.
11. Concomitant serious illness or medical condition that may interfere with
participation in the study including renal failure, hepatic failure or systemic lupus
12. Subject currently enrolled in another investigational device or drug trial(s), or
that may compromise the safety of data collection.
13. Any condition judged by the investigator to cause this clinical trial to be
detrimental to the patient.
14. Subject known to be pregnant or breastfeeding.
15. Evidence of skin conditions (e.g.,eczema) other than psoriasis that would interfere
with study-related evaluations of psoriasis.
16. History of psychiatric disease that would interfere with the patient's ability to
comply with the study protocol.
17. History of non-compliance with other therapies.
- Investigator: Jerry Bagel, M.D. - Principal Investigator - Psoriasis Treatment Center of Central New Jersey