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

This study is currently recruiting participants.
Verified February 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Adelaide Hebert, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01137448
First received: June 3, 2010
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Psoriasis
Obesity
 Behavioral: Weight Loss

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Severity of psoriasis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.


Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137448

Contacts
Contact: Maria Lopez 7135008266 Maria.d.lopez@uth.tmc.edu

Locations
United States, Texas
University of Texas Dermatology Clinical Research Recruiting
Houston, Texas, United States, 77030
Contact: Maria Lopez     713-500-8266     maria.d.lopez@uth.tmc.edu    
Principal Investigator: Adelaide Hebert, MD            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
Investigators
Principal Investigator: Adelaide Hebert, MD University of Texas Medical School - Houston
  More Information

No publications provided

Responsible Party: Adelaide Hebert, Professor, Director - Pediatric Dermatology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01137448     History of Changes
Other Study ID Numbers: 5 T35 DK007676-18
Study First Received: June 3, 2010
Last Updated: February 15, 2012
Health Authority: United States: Committee for the Protection of Human Subjects

Keywords provided by The University of Texas Health Science Center, Houston:
Psoriasis
Obesity

Additional relevant MeSH terms:
Obesity
Psoriasis
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Skin Diseases, Papulosquamous
Skin Diseases
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013