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

This study has been completed.
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Jerry Bagel MD, Bagel, Jerry, M.D.
ClinicalTrials.gov Identifier:
NCT00537212
First received: September 28, 2007
Last updated: February 1, 2012
Last verified: February 2012
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Bagel, Jerry, M.D.:

Primary Outcome Measures:
  • PASI improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • which group's PASI did better [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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."
Other Name: 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.
Other Name: The Ornish Diet
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537212

Locations
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)
Investigators
Principal Investigator: Jerry Bagel, M.D. Psoriasis Treatment Center of Central New Jersey
  More Information

No publications provided

Responsible Party: Jerry Bagel MD, Director, Bagel, Jerry, M.D.
ClinicalTrials.gov Identifier: NCT00537212     History of Changes
Other Study ID Numbers: P0-001
Study First Received: September 28, 2007
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 23, 2014