A Controlled Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Pruritus in Adult Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Investigator Global Assessment
研究概览
简要总结
The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled comparative trial.
详细描述
This was a 4-week, randomized, double-blind, controlled study. Fourteen subjects received treatment lotion (1% pramoxine HCl) and the remaining 14 received a bland emollient (Cetaphil lotion). A target lesion limited to one anatomic site, excluding face and genitals, was selected at baseline. Each subject was instructed to apply lotion twice daily to all affected areas of pruritus for four weeks. The use of any other topical or systemic medication to treat uremic pruritus was not permitted while participating in the study. Subjects were clinically evaluated for erythema, xerosis, lichenification and overall severity at baseline, week 1, and week 4 (end of study)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years of age to 70 years of age.
- •A diagnosis of moderate to severe pruritus.
- •At least 3 episodes of itch over a period of 2 weeks, each lasting for 2 minutes or more.
- •Symptoms of itch in regular pattern over 6 months.
- •Itch Visual analog scale (VAS) of 3cm or more out of 10 cm.
- •All subjects will be end stage renal failure patients undergoing hemodialysis for at least 3 months, who have substantial pruritus for more than 6 months. Substantial pruritus is defined as persistent pruritus impairing sleep or daytime activity.
- •Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
- •The ability to understand and sign a written informed consent form, which must be obtained prior to treatment.
排除标准
- •Presence of infection (as defined by the investigator) on the area to be treated.
- •Subjects with history of pruritus predating renal failure and subjects with skin disease unrelated to uremia, such as atopic dermatitis, will be excluded.
- •Use of systemic medications for treatment of pruritus including corticosteroids within the past 4 weeks and during the study.
- •Use of topical medications for treatment of pruritus, including corticosteroids, within the past week.
- •Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study.
研究组 & 干预措施
Sarna Lotion
1% pramoxine Sarna lotion
干预措施: Sarna (Drug)
Placebo Cetaphil lotion
Placebo Cetaphil lotion
干预措施: Cetaphil (Drug)
结局指标
主要结局
Investigator Global Assessment
时间窗: Disease severity assessed at baseline and 4 weeks, week 4 reported
Investigator's Global Assessment Disease Severity is based on the following scale: 0 = completely clear: except for possible residual hyper pigmentation 1. = almost clear: very significant clearance (about 90%) 2. = Marked improvement: significant improvement (about 75%) 3. = Moderate improvement: intermediate between slight and marked; representing about 50% improvements 4. = Slight improvement: some improvement (about 25%); however, significant disease remaining 5. = No change (moderate to severe disease) 6. = Worse
次要结局
- VAS of Pruritus(Assessed at baseline and 4 weeks, week 4 reported)