Study of the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy - Full Text View

Sponsor:	Bagel, Jerry, M.D.
Collaborator:	Food and Drug Administration (FDA)
Information provided by (Responsible Party):	Jerry Bagel MD, Bagel, Jerry, M.D.
ClinicalTrials.gov 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.

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

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:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Obesity Psoriasis Weight Control

U.S. FDA Resources

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:

Age greater than 18
PASI score greater than 10
BMI greater than 25
Subjects must be willing and eligible to undergo phototherapy and
Willing to stop all other psoriasis therapies

Exclusion Criteria:

History of failure to respond to NB-UVB in the past.
Presence of predominantly guttate, erythrodermic, or pustular psoriasis or any skin condition that would interfere with evaluation of effect of study. intervention .
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.
Use or oral or parenteral corticosteroids.
Use of appetite suppressants or other medications know to affect appetite or weight.
Treatment with biologic therapy in the past 3 months.
History of cutaneous malignancy, including any squamous cell carcinoma or melanoma or more than two basal cell carcinomas, current actinic keratoses or atypical moles.
Evidence of photosensitivity disorder (e.g.polymorphous light eruption.
Use of other investigational drugs, any systemic psoriasis therapy, psoralen plus ultraviolet A therapy (PUVA) within 4 weeks of study drug initiation.
Subjects who are currently achieving good clinical control of their psoriasis on their current therapy.
Concomitant serious illness or medical condition that may interfere with participation in the study including renal failure, hepatic failure or systemic lupus erythematosus.
Subject currently enrolled in another investigational device or drug trial(s), or that may compromise the safety of data collection.
Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
Subject known to be pregnant or breastfeeding.
Evidence of skin conditions (e.g.,eczema) other than psoriasis that would interfere with study-related evaluations of psoriasis.
History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol.
History of non-compliance with other therapies.

Contacts and Locations

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:

Psoriasis
Weight Loss
Overweight
Skin Diseases, Papulosquamous

Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012