跳至主要内容
临床试验/NCT06458868
NCT06458868已完成不适用

An Open-label Controlled Trial: Effectiveness of Saltwater-UVA, Tap Water-UVA, and Bath PUVA in the Treatment of Palmoplantar Psoriasis and Contact Dermatitis.

Ankara University2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2014年6月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilayda Karakok Kısla

Doctor

Ankara University

研究点 (2)

Loading locations...

相似试验