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

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ClinicalTrials.gov Identifier: NCT01137448
Recruitment Status : Withdrawn (The site did not have enough funds to complete study arrengments and start to enrolling. The site was not able to enroll subjects.)
First Posted : June 4, 2010
Last Update Posted : December 16, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Psoriasis Obesity Behavioral: Weight Loss

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
Study Start Date : June 2010
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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%.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137448

United States, Texas
University of Texas Dermatology Clinical Research
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
Principal Investigator: Adelaide Hebert, MD University of Texas Medical School - Houston
More Information

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: 5T35DK007676-18 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013

Keywords provided by Adelaide Hebert, The University of Texas Health Science Center, Houston:

Additional relevant MeSH terms:
Weight Loss
Skin Diseases, Papulosquamous
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms