A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of treatments required to reach clearance
研究概览
简要总结
Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B (NBUVB) units have become available which allow for light treatment without soaking first. The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot skin diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.
排除标准
- •Age <18 years Pregnancy Liver disease Kidney disease History of skin cancer Phototherapy or systemic therapy for the skin condition in the preceding 3 months
研究组 & 干预措施
Narrowband Ultraviolet B (TL-01UVB) Therapy
treatments - 3x weekly for 15 months
干预措施: Narrowband Ultraviolet B (TL-01UVB) Therapy (Procedure)
Topical Psoralen plus ultraviolet A (PUVA)
Treatments - 3x weekly for 15 months
干预措施: Topical Psoralen plus ultraviolet A (PUVA) (Procedure)
结局指标
主要结局
Number of treatments required to reach clearance
时间窗: Baseline to 15 months
次要结局
- Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)(Baseline to 15 months)
- Change in global score(Baseline to 15 months)
- Number of patients reaching clearance(Baseline to 15 months)
- Adverse effects(Baseline to 15 months)
- Number of days in remission(Baseline to 15 months)