The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Severity of psoriasis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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)
排除标准
- •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
结局指标
主要结局
Severity of psoriasis
时间窗: 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%.
次要结局
- Serum TNF-alpha levels(6 months)
研究者
Adelaide Hebert
Professor, Director - Pediatric Dermatology
The University of Texas Health Science Center, Houston