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

Primary Purpose

Psoriasis, Weight Loss, Diet

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

The South Beach Diet

The Ornish Diet

Control Group

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Weight loss, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Jerry Bagel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

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

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

Subjects will receive phototherapy alone, without dietary counselling.

Outcomes

Primary Outcome Measures

PASI improvement

Secondary Outcome Measures

which group's PASI did better

Full Information

NCT ID

NCT00537212

First Posted

September 28, 2007

Last Updated

August 12, 2019

Sponsor

Bagel, Jerry, M.D.

Collaborators

Food and Drug Administration (FDA)

1. Study Identification

Unique Protocol Identification Number

NCT00537212

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bagel, Jerry, M.D.

Collaborators

Food and Drug Administration (FDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis, Weight Loss, Diet

Keywords

Psoriasis, Weight loss, diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Sham Comparator

Arm Description

Subjects will receive phototherapy alone, without dietary counselling.

Intervention Type

Other

Intervention Name(s)

The South Beach Diet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

The Ornish Diet

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control Group

Other Intervention Name(s)

Phototherapy only

Intervention Description

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

Primary Outcome Measure Information:

Title

PASI improvement

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

which group's PASI did better

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerry Bagel, M.D.

Organizational Affiliation

Psoriasis Treatment Center of Central New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jerry Bagel

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

12. IPD Sharing Statement

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

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