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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00537212 |
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Date of registration:
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28/09/2007 |
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Primary sponsor: |
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Public title:
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Study of the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
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Scientific title:
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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 |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00537212 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jerry Bagel, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Psoriasis Treatment Center of Central New Jersey |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diet
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Psoriasis
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Weight Loss
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Intervention(s)
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Other: Control Group
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Other: The Ornish Diet
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Other: The South Beach Diet
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Primary Outcome(s)
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PASI improvement
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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which group's PASI did better
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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