The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
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 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|
- 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%.
- 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.
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
|Contact: Maria Lopez||7135008266||Maria.firstname.lastname@example.org|
|United States, Texas|
|University of Texas Dermatology Clinical Research||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maria Lopez 713-500-8266 email@example.com|
|Principal Investigator: Adelaide Hebert, MD|
|Principal Investigator:||Adelaide Hebert, MD||University of Texas Medical School - Houston|