Study of the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537212
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : February 2, 2012
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Jerry Bagel MD, Bagel, Jerry, M.D.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Weight Loss Diet Other: The South Beach Diet Other: The Ornish Diet Other: Control Group Phase 4

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  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Prospective, Single-Blinded, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
Study Start Date : June 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet."
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."
Active Comparator: 2
Subjects will receive phototherapy and dietary counselling consistent with "The Ornish 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.
No Intervention: 3
Subjects will receive phototherapy alone, without dietary counselling.
Other: Control Group
This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet.

Primary Outcome Measures :
  1. PASI improvement [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. which group's PASI did better [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00537212

United States, New Jersey
Jerry Bagel
East Windsor, New Jersey, United States, 08520
Sponsors and Collaborators
Bagel, Jerry, M.D.
Food and Drug Administration (FDA)
Principal Investigator: Jerry Bagel, M.D. Psoriasis Treatment Center of Central New Jersey

Responsible Party: Jerry Bagel MD, Director, Bagel, Jerry, M.D. Identifier: NCT00537212     History of Changes
Other Study ID Numbers: P0-001
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Jerry Bagel MD, Bagel, Jerry, M.D.:
Weight loss

Additional relevant MeSH terms:
Weight Loss
Skin Diseases, Papulosquamous
Skin Diseases
Body Weight
Signs and Symptoms
Body Weight Changes