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

Not Applicable

Withdrawn

• Conditions: Obesity; Psoriasis
• Interventions: Behavioral: Weight Loss

• Registration Number: NCT01137448
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight Loss	Weight Loss	Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.

Primary Outcome Measures

Name	Time	Method
Severity of psoriasis	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

Name	Time	Method
Serum TNF-alpha levels	6 months	Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.

Trial Locations

Locations (1)

University of Texas Dermatology Clinical Research; 🇺🇸 Houston, Texas, United States