A Single-Center, Prospective, Single-Blinded, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- PASI improvement
研究概览
简要总结
The association between psoriasis and obesity has been questioned by physicians for many years. Studies have shown that the risk of having psoriasis is increased in people with a high body mass index, which is a measurement of obesity. There have been case reports of remission of psoriasis after gastric bypass surgery. Furthermore, other studies have shown that certain inflammatory diseases (such as rheumatoid arthritis) can be improved by dietary changes. The purpose of this study is to assess whether a low carbohydrate or low fat diet can be helpful in the treatment of psoriasis.
详细描述
This study involves the use of diet as a therapeutic agent in subjects with obesity and psoriasis who are eligible for and willing to undergo phototherapy. Subjects undergoing phototherapy alone will be compared to subjects randomized to receive phototherapy and dietary modification with the goal of weight loss. The primary objective is to determine the success rate of weight loss programs in the setting of psoriasis. Secondary objectives include evaluating the effect of weight loss on efficacy of narrow band ultraviolet B phototherapy, and assessing the efficacy of lower carbohydrate and low fat diets in psoriatic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Age greater than 18
- •PASI score greater than 10
- •BMI greater than 25
- •Subjects must be willing and eligible to undergo phototherapy and
- •Willing to stop all other psoriasis therapies
排除标准
- •History of failure to respond to NB-UVB in the past.
- •Presence of predominantly guttate, erythrodermic, or pustular psoriasis or any skin condition that would interfere with evaluation of effect of study. intervention .
- •Treatment with systemic antibiotics, topical steroids (except to groin and face), topical Vitamin A or D analogs, or ultraviolet B therapy within 2 weeks of study initiation.
- •Use or oral or parenteral corticosteroids.
- •Use of appetite suppressants or other medications know to affect appetite or weight.
- •Treatment with biologic therapy in the past 3 months.
- •History of cutaneous malignancy, including any squamous cell carcinoma or melanoma or more than two basal cell carcinomas, current actinic keratoses or atypical moles.
- •Evidence of photosensitivity disorder (e.g.polymorphous light eruption.
- •Use of other investigational drugs, any systemic psoriasis therapy, psoralen plus ultraviolet A therapy (PUVA) within 4 weeks of study drug initiation.
- •Subjects who are currently achieving good clinical control of their psoriasis on their current therapy.
- •Concomitant serious illness or medical condition that may interfere with participation in the study including renal failure, hepatic failure or systemic lupus erythematosus.
- •Subject currently enrolled in another investigational device or drug trial(s), or that may compromise the safety of data collection.
- •Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
- •Subject known to be pregnant or breastfeeding.
- •Evidence of skin conditions (e.g.,eczema) other than psoriasis that would interfere with study-related evaluations of psoriasis.
- •History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol.
- •History of non-compliance with other therapies.
研究组 & 干预措施
2
Subjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet."
干预措施: The Ornish Diet (Other)
1
Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet."
干预措施: The South Beach Diet (Other)
3
Subjects will receive phototherapy alone, without dietary counselling.
干预措施: Control Group (Other)
结局指标
主要结局
PASI improvement
时间窗: 12 weeks
次要结局
- which group's PASI did better(12 weeks)
研究者
Jerry Bagel MD
Director
Bagel, Jerry, M.D.