The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
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ClinicalTrials.gov Identifier: NCT01137448 |
Recruitment Status
:
Withdrawn
(The site did not have enough funds to complete study arrengments and start to enrolling. The site was not able to enroll subjects.)
First Posted
: June 4, 2010
Last Update Posted
: December 16, 2013
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Condition or disease | Intervention/treatment | Phase |
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Psoriasis Obesity | Behavioral: Weight Loss | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Weight Loss
Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.
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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.
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- Severity of psoriasis [ Time Frame: 6 months ]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%.
- Serum TNF-alpha levels [ Time Frame: 6 months ]Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137448
United States, Texas | |
University of Texas Dermatology Clinical Research | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Adelaide Hebert, MD | University of Texas Medical School - Houston |
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 ( U.S. NIH Grant/Contract ) |
First Posted: | June 4, 2010 Key Record Dates |
Last Update Posted: | December 16, 2013 |
Last Verified: | December 2013 |
Keywords provided by Adelaide Hebert, 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 |