An Open-label Controlled Trial: Effectiveness of Saltwater-UVA, Tap Water-UVA, and Bath PUVA in the Treatment of Palmoplantar Psoriasis and Contact Dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Disease Severity Reduction
研究概览
简要总结
Patients who had an indication for phototherapy were included in this study. The treatment was used as a monotherapy protocol.
The standard protocol for bathing PUVA involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3% salted (NaCl) water before UVA treatment.
Main tools to assess the efficacy is disease activity scores and quaity of Life scores.
详细描述
Patients who met the criteria for phototherapy were included in this study. The treatment was used as a standalone protocol, with only moisturizer permitted. In order to participate, patients needed to have completed their last systemic treatment at least 2 months prior to the study, and their last topical treatment at least 4 weeks prior.
Patients were randomized using a computer program and assessed at the beginning of therapy, as well as after 12, 24, and 36 sessions. The standard bath-PUVA protocol involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes, and the salt water group received a 3% salt water bath before UVA exposure.
All patients were educated about their condition and current treatment options. Patients who participated in this study either had contraindications to other therapies or had experienced side effects previously.
The initial UVA dosage was 0.25 J/cm2, gradually increasing to a maximum of 5 J/cm2. During each evaluation, patients were assessed using various scales and tools to measure the severity of their psoriasis and their quality of life, as well as photographs.
Following a pilot study involving 5 patients in each group, a two score reduction in the disease activity score revealed that G power analysis determined that a total of at least 13 patients was needed to achieve 80% power. Ethical approval was obtained before commencing the 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
- None
盲法说明
Endpoint assessors blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18 and 65
- •Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis
排除标准
- •Individuals under 18 or over 65
- •Pregnancy or breastfeeding
- •History of malignancy
- •Diagnosis of photodermatosis
- •Prescription or use of photoallergenic or phototoxic drugs
结局指标
主要结局
Disease Severity Reduction
时间窗: Disease Severity
At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment
次要结局
- Improvevement in the Quality of Life(Qol)
研究者
Hilayda Karakok Kısla
Doctor
Ankara University
