The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
This study has been withdrawn prior to enrollment.
(The site did not have enough funds to complete study arrengments and start to enrolling. The site was not able to enroll subjects.)
Sponsor:
The University of Texas Health Science Center, Houston
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Adelaide Hebert, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01137448
First received: June 3, 2010
Last updated: December 12, 2013
Last verified: December 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Psoriasis Obesity |
Behavioral: Weight Loss |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients |
Resource links provided by NLM:
Further study details as provided by The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- Severity of psoriasis [ Time Frame: 6 months ] [ Designated as safety issue: No ]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:
- Serum TNF-alpha levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.
| Enrollment: | 0 |
| Study Start Date: | June 2010 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Weight Loss
Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137448
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137448
Locations
| United States, Texas | |
| University of Texas Dermatology Clinical Research | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
Investigators
| Principal Investigator: | Adelaide Hebert, MD | University of Texas Medical School - Houston |
More Information
| Responsible Party: | Adelaide Hebert, Professor, Director - Pediatric Dermatology, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT01137448 History of Changes |
| Other Study ID Numbers: | 5T35DK007676-18 |
| Study First Received: | June 3, 2010 |
| Last Updated: | December 12, 2013 |
| Health Authority: | United States: Committee for the Protection of Human Subjects |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Psoriasis Obesity |
Additional relevant MeSH terms:
|
Psoriasis Weight Loss Skin Diseases, Papulosquamous Skin Diseases |
Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on September 23, 2016