跳至主要内容
临床试验/NCT02713711
NCT02713711已完成不适用

Comparison of the Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis: A Randomized, Controlled Trial

Universidad Católica del Maule0 个研究点目标入组 14 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
主要终点
Percentage Change in Psoriatic Plaque Area

研究概览

简要总结

The purpose of this study is to compare the effectiveness of artificial balneotherapy (AB), phototherapy (PT) and artificial balneophototherapy (BPT) in the treatment of plaque psoriasis, evaluating the plaque area, alteration of skin pigmentation, Psoriasis Area and Severity Index (PASI) score determination and quality-of-life assessment by Short Form 36 Health Survey (SF-36) and Psoriasis Disability Index (PDI) scores during the month of treatment. Methods: Experimental study, prospective, randomized, single-blind. 14 subjects participated from the city of Talca, Chile medically diagnosed with psoriasis, more than one plaque in the skin without topical treatment voluntarily. All subjects completed the study that consisted of 12 sessions.

详细描述

On the selected subjects, it was also performed the evaluation of Minimal Erythema Dose (MED) in order to determine an acceptable dose of UV-B light for the type of skin of each patient. Thus, the evaluations were performed according to psoriasis type, area, color and plaques severity. The formula used for the calculation was:

MED = 2×t(s)×0,75 t: minimum time for erythema occurrence.

Each psoriatic plaque was submitted to three therapeutic sessions per week, during 4 weeks, for a total of 12 sessions.

For the application of AB, the AB group plaques were immersed during 15 minutes in a 35 or 75 l hydrotherapy whirlpool (TB-T45 model and TB-T90 model respectively, Enraf Nonius Company SA, Spain) filled with a solution of warm water (32 °C) and natural sea salt (250 g/L), following the similar protocol of others authors always ensuring that the plaques not receiving this treatment were kept isolated with flexible and insulating adhesive patches (Nexcare® Factory 3M, Chile).

For the implementation of PT, the PT group plaques that would not receive radiation were covered with thick cloth towels, while the healthy skin surrounding the treated plaques were coated with liquid petroleum jelly. Both patients and attendant were protected with special lenses with filter against UV light (Oakley Jupiter, USA). UV-B radiation was applied with the UV Endolamp 474 device (Enraf Nonius Company SA, Spain), 60 cm away from the plaque and in a perpendicular position. In session 1, the MED was calculated for each subject and used as the time of UV-B exposure. On each further session, the exposure time was increased by 25%, until the limit of 5 minutes.

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • be more than 18 years-old,
  • have more than one plaque on the skin,
  • medically diagnosed as plaque psoriasis over a year ago and,
  • without concurrent topical treatment for Psoriasis (by own choice).

排除标准

  • pregnancy,
  • skin carcinoma,
  • severe diabetes mellitus,
  • uncontrolled chronic pathologies and/or severe cardiac/renal insufficiency and/or acute infections.

结局指标

主要结局

Percentage Change in Psoriatic Plaque Area

时间窗: Before first session (day 1), after the six session (day 12) and after the twelve session (day 26)

The plaques were photographed at a distance of 20 cm with a 12 pixel Lumix digital camera (Panasonic, USA). For area quantification, the photographs were taken before session 1 and a day after session 6 and 12, and were analyzed with ImageJ software (version 1.46j; National Institute of Health, MD, USA). A single area value was calculated per psoriatic plaque after twelve sessions (percentage of decrease).

次要结局

  • Number of Participants With Change in PASI From Baseline to Session 12(Before first session (day 1) and after the twelve session (day 26))
  • Arbitrary Units Change in Psoriatic Plaque Erythema(Before first session (day 1) and after the twelve session (day 26))
  • Number of Participants With Change in Psoriasis Disability(Session 1 and session 12)
  • Number of Participants With Change in Quality of Life(Before first session (day 1) and after the twelve session (day 26))

研究者

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

Gabriel Nasri Marzuca Nassr

PT; MSc

Universidad Católica del Maule

相似试验