Pilot Studies Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in pain level from baseline with placebo.
研究概览
简要总结
The objective of this double-blinded placebo-controlled cross-over study is to define the role of the over the counter agent, N-acetyl cysteine (NAC), in mitigating the development of pruritus (skin itching). The study is designed to have all subjects treated with a seven-day regimen of both NAC and placebo. NAC will be prescribed at a dose of 1,500 mg twice daily for seven days. Subjects will initially be randomly assigned (1:1) to either the NAC or placebo arm of the study, before crossing over to the opposite arm after completing a minimum of 30-day washout period. The study will encompass a period of approximately 11 weeks (about 2 and a half months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females
- •All skin types (Fitzpatrick types I - VI)
- •Age 18 - 40
- •Able to comprehend procedures and risks
排除标准
- •Currently taking immunosuppressive or immunomodulating or psychotropic medications.
- •This includes antihistamines and aspirin-like anti-inflammatory medications (NASIDs) for the past month.
- •History of peripheral neuropathy, Charcot-Marie-Tooth, familial dysautonomia or heavy metal toxicity
- •History of gastrointestinal abnormalities (including irritable bowel syndrome)
- •History of inadequately controlled Diabetes Mellitus
- •History of abnormal scarring
- •History of skin infections within 6 weeks
- •History of skin disease (atopic dermatitis, psoriasis, xerosis) or "sensitive skin"
- •Pregnancy or nursing
- •Other serious health issues, including liver or kidney disease
研究组 & 干预措施
N-acetyl Cysteine then Placebo
Subjects will be treated with N-acetyl cysteine twice daily for seven days. Subject will complete a minimum of 30-day washout period before crossing over to take the placebo.
干预措施: N-acetyl cysteine (Drug)
N-acetyl Cysteine then Placebo
Subjects will be treated with N-acetyl cysteine twice daily for seven days. Subject will complete a minimum of 30-day washout period before crossing over to take the placebo.
干预措施: Placebo (Drug)
Placebo then N-acetyl Cysteine
Subjects will be treated with placebo twice daily for seven days. Subject will complete a minimum of 30-day washout period before crossing over to take N-acetyl cysteine.
干预措施: N-acetyl cysteine (Drug)
Placebo then N-acetyl Cysteine
Subjects will be treated with placebo twice daily for seven days. Subject will complete a minimum of 30-day washout period before crossing over to take N-acetyl cysteine.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in pain level from baseline with placebo.
时间窗: 7 days
The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).
Change in pain level from baseline with NAC.
时间窗: 7 days
The change will be assessed from the Skin Pain Visual Analogue Scale (0 = no skin pain to 10 = severe skin pain).
Change in itch level from baseline with NAC.
时间窗: 7 days
The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).
Change in itch level from baseline with placebo.
时间窗: 7 days
The change will be assessed from the Skin Itch Visual Analogue Scale (0 = no skin itch to 10 = severe skin itch).
次要结局
未报告次要终点