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

Primary Purpose

Psoriasis, Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Obesity

Eligibility Criteria

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

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

Sites / Locations

  • University of Texas Dermatology Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Loss

Arm Description

Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.

Outcomes

Primary Outcome Measures

Severity of psoriasis
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%.

Secondary Outcome Measures

Serum TNF-alpha levels
Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.

Full Information

First Posted
June 3, 2010
Last Updated
December 12, 2013
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01137448
Brief Title
The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
Official Title
The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Why Stopped
The site did not have enough funds to complete study arrengments and start to enrolling. The site was not able to enroll subjects.
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Loss
Arm Type
Experimental
Arm Description
Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Intervention Description
Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.
Primary Outcome Measure Information:
Title
Severity of psoriasis
Description
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%.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum TNF-alpha levels
Description
Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaide Hebert, MD
Organizational Affiliation
University of Texas Medical School - Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Dermatology Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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