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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psoriasis, Obesity

Intervention / Treatment
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* Behavioral: Weight Loss


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss<br>Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling. | Behavioral: Weight Loss<br>* Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of psoriasis | 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%. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum TNF-alpha levels | Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Obesity