The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
|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Recruitment Status : Withdrawn (The site did not have enough funds to complete study arrengments and start to enrolling.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
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Obesity||Behavioral: Weight Loss||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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.
- 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%.
- 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.
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|
|Principal Investigator:||Adelaide Hebert, MD||University of Texas Medical School - Houston|