A 12-Week, Multicenter, Double-Blind, Controlled, Randomized Study Assessing Change in Psoriasis Severity and Level of Stress in Patients With Moderate to Severe Psoriasis Using Transdermal Electrical Neurosignaling (TEN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Proportion of subjects who reach PASI 75 (75% reduction in PASI score from Baseline)
研究概览
简要总结
This is a 12-Week, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate to severe psoriasis treated with TEN. Psoriasis severity and stress levels will be measured at Weeks 0, 4, 8 and 12.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Outpatient, male or female of any race, 18 years of age or older.
- •Moderate (>3 to <10% BSA) with a PASI of at least 6 and less than 12 or severe (≥10% BSA) plaque psoriasis with a minimal PASI score of
- •Subject diagnosed with psoriasis at least 6 months prior to entering the study.
- •Subjects who have received treatment in the past for psoriasis and are currently untreated or subjects who are on stable treatment for psoriasis that is expected to remain unchanged throughout the entire duration.
- •Subjects who have not received psoriasis treatments in the past should be stable in their disease for the last 4 weeks.
排除标准
- •Guttate, erythrodermic, or pustular psoriasis subtypes.
- •Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- •Unstable psoriasis or unstable treatment of psoriasis over the entire duration of the study.
- •Subjects with moderate psoriasis are not allowed to use concurrent systemic therapies for psoriasis (i.e., phototherapy, orals, biologics, etc.). Topical medications are allowed;
- •Subjects with severe psoriasis are allowed to use any concurrent therapy for psoriasis, provided that disease state is stable for ≥2 months and they meet minimum PASI requirements.
- •Cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.
研究组 & 干预措施
TEN 1-11 kHz
Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-11 kHz)
干预措施: Transdermal Electrical Neuromodulator (TEN) (Device)
TEN 1-3 kHz
Transdermal Electrical Neuromodulator (TEN) waveform pulsed biphasic current (1-3 kHz)
干预措施: Transdermal Electrical Neuromodulator (TEN) (Device)
结局指标
主要结局
Proportion of subjects who reach PASI 75 (75% reduction in PASI score from Baseline)
时间窗: Week 4, 8, and 12
Standard Psoriasis Area and Severity Index (PASI) scoring system, which incorporates erythema, induration, and scale (0-4) weighted by percentage of body surface area involvement.
Proportion of subjects who reach PASI 50 (50% reduction in PASI score from Baseline)
时间窗: Week 4, 8, and 12
Standard Psoriasis Area and Severity Index (PASI) scoring system, which incorporates erythema, induration, and scale (0-4) weighted by percentage of body surface area involvement.
次要结局
- PASI change from Baseline(Week 4, 8, and 12)
- IGA Responder Rate(Week 4, 8, and 12)
- IGA change from Baseline(Week 4, 8, and 12)
- DLQI change from Baseline(Week 4, 8, and 12)
- PQOL-12 change from Baseline(Week 4, 8, and 12)
- HADS change from Baseline(Week 4, 8, and 12)
- QVAS change from Baseline(Week 4, 8, and 12)
- Pruritus NRS change from Baseline(Week 4, 8, and 12)