NCT03392337招募中不适用
An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psoriasis area severity index score
研究概览
简要总结
A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.
详细描述
30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female adults ≥ 18 years of age.
- •Diagnosis of chronic plaque-type psoriasis for at least 6 months
- •Moderate to Severe plaque psoriasis as defined by BSA ≥10 PASI ≥12 IGA ≥3
- •Able to give written informed consent prior to performance of any study related procedures
- •Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits
- •Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
排除标准
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis
- •History of photosensitivity
- •Subject has used ustekinumab and/or anti-IL-17 biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- •Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- •Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
- •Patient used topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
- •Initiated within 3 months, planned initiation of, or changes to, concomitant medications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors ) during the trial
- •Active infections requiring antibiotics in the 2 weeks prior to Baseline
- •Patient received UVB phototherapy within 4 weeks of Baseline.
- •Patient received PUVA phototherapy within 4 weeks of Baseline.
研究组 & 干预措施
Open Label Narrowband UVB phototherapy
Experimental
Open Label Narrowband UVB phototherapy for 12 weeks.
干预措施: Narrowband UVB phototherapy (Device)
结局指标
主要结局
Psoriasis area severity index score
时间窗: 12 weeks
PASI 75
次要结局
- Physicians Global Assessment(12 weeks)
- Body Surface Area(12 weeks)
- Physician's Global Assessments multiplied by Body surface area(12 weeks)
研究者
研究点 (1)
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