View Clinical Trial (Medical Research Study)
Study of the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy - NCT00537212-08520(Clinical Trial 186404)
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| City: |
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East Windsor |
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State:
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NJ |
| Zip Code: |
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08520 |
| Conditions: |
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Psoriasis - Weight Loss - Diet |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
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
Exclusion Criteria:
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
initiation.
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
erythematosus.
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. |
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| Study is available at: |
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Jerry Bagel
East Windsor, NJ 08520
United States
Primary Contact:
Kim Raynor, LPN
Phone: 609-443-4501 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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