NCT01137448

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

2.9 years

First QC Date

June 3, 2010

Last Update Submit

December 12, 2013

Conditions

PsoriasisObesity

Keywords

PsoriasisObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Serum TNF-alpha levels

    6 months

Study Arms (1)

Weight Loss

EXPERIMENTAL

Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.

Behavioral: Weight Loss

Interventions

Weight LossBEHAVIORAL

Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.

Weight Loss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Dermatology Clinical Research

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

PsoriasisObesity

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adelaide Hebert, MD

    University of Texas Medical School - Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director - Pediatric Dermatology

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 4, 2010

Study Start

June 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

US(1)