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

NCT00537212 | Completed DMC

• 1 other identifier: P0-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Weight Loss; Diet

Keywords

Psoriasis; Weight loss; diet

Outcome Measures

Primary Outcomes (1)

• PASI improvement

  12 weeks

Secondary Outcomes (1)

• which group's PASI did better

  12 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet."

Other: The South Beach Diet

2

ACTIVE COMPARATOR

Subjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet."

Other: The Ornish Diet

3

SHAM COMPARATOR

Subjects will receive phototherapy alone, without dietary counselling.

Other: Control Group

Interventions

The South Beach Diet OTHER

Subjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss. Subjects also receive a copy of "The South Beach Diet."

1

The Ornish Diet OTHER

Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of "The Ornish Diet" book.

2

Control Group OTHER

This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet.

Also known as: Phototherapy only

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bagel, Jerry, M.D.: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Jerry Bagel

East Windsor, New Jersey, 08520, United States

Location

MeSH Terms

Conditions

Psoriasis; Weight Loss

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jerry Bagel, M.D.

  Psoriasis Treatment Center of Central New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)