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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Withdrawn

Conditions

Psoriasis
Obesity

Treatments

Behavioral: Weight Loss

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01137448
5T35DK007676-18

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Weight Loss
Experimental group
Description:
Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.
Treatment:
Behavioral: Weight Loss

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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