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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

Sponsor: Bagel, Jerry, M.D.
Collaborators:
Information provided by: Bagel, Jerry, M.D.
Identifier: NCT00537212

Purpose

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 Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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.

Investigators

  • Investigator: Jerry Bagel, M.D. - Principal Investigator - Psoriasis Treatment Center of Central New Jersey

Locations

  • Jerry Bagel

    East Windsor, New Jersey 08520 United States

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