The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients

December 12, 2013 updated by: Adelaide Hebert, The University of Texas Health Science Center, Houston
The purpose of this study is to evaluate the effect that weight loss has on the severity of psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program. The severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to determine what effect weight loss has had on their psoriasis. Serum TNF-alpha will be measured at month 0 and month 6. The hypothesis that will be tested is that weight loss will lead to a significant improvement in the severity of psoriasis and a reduction in TNF-alpha levels.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Dermatology Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years of age
  • A Body Mass Index (BMI) >/= 30
  • Subject has plaque psoriasis
  • A Psoriasis Area Severity Index (PASI) score >/= 10 or a total body surface area (BSA) affected by psoriasis >/= 10%
  • Capable of reading, understanding, and signing a consent form
  • Females of childbearing potential must have negative urine pregnancy test on Day 0, and agree to a medically effective method of birth control (as determined by the investigator)

Exclusion Criteria:

  • Already participating in a study for weight loss or a study of other psoriasis treatments
  • If they are on systemic therapy for their psoriasis
  • Female subjects who are pregnant or planning to become pregnant
  • Patients with a history of anorexia nervosa, bulimia, or other diseases that would make a weight loss program a risk to their health
  • Subjects unable to comply with study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Weight Loss
Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.
Behavioral: Weight Loss
Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of psoriasis
Time Frame: 6 months
The Psoriasis Area Severity Index (PASI) is the most common validated psoriasis severity assessment tool used in clinical trials, and combines redness, thickness, and scaliness of skin lesions with the body surface area that is affected. Most clinical trials define moderate to severe psoriasis as a PASI score of greater than or equal to 10, or a total Body Surface Area (BSA) of greater than or equal to 10%.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum TNF-alpha levels
Time Frame: 6 months
Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Adelaide Hebert, MD, University of Texas Medical School - Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (ESTIMATE)

June 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5T35DK007676-18 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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