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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01137448
• Other study ID #: 5T35DK007676-18
• Status: Withdrawn
• Phase: N/A
• First received: June 3, 2010
• Last updated: December 12, 2013
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: December 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Committee for the Protection of Human Subjects
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Dermatology Clinical Research	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum TNF-alpha levels	Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.	6 months	No