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临床试验/NCT02098213
NCT02098213已完成不适用

Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study

Association Francaise pour la Recherche Thermale10 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
10
主要终点
Dermatology Quality of Life Index (DQLI)

研究概览

简要总结

Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.

详细描述

Psoriasis is one of the most common skin diseases, affecting 2-3% of the general population; more than 1 million people in France.

This auto-immune erythematosquamous inflammatory dermatosis occurs on a particular genetic background and has a chronic course. Psoriasis has a history as an indication for dermatological spa treatment (water cures in the Dead Sea). As these treatments are a combination of balneotherapy and heliotherapy, many recent studies have attempted to assess the value and position the relative benefit of each therapeutic element. Over the last four decades various different phototherapy techniques have been widely used in the treatment of psoriasis. The thermal option for many psoriasis patients depends on personal choice, or their doctor's or dermatologist's recommendation. In 1994 only one third of the 16,875 spa treatments for dermatological conditions (about 5625 cures) were for psoriasis, suggesting that spa treatment is underused as a treatment for psoriasis. Nobody can challenge the therapeutic contribution of biotherapy in the treatment of anatomically destructive diseases such as rheumatoid arthritis and psoriatic arthritis, but the use of these treatments is not without risk and economic impact. There is thus a need for less intensive treatments that have little risk of serious side effects and are less expensive.

The use of spa therapy in psoriasis should be understood as complementary and not an alternative to all other treatments. The choice of treatment is guided by the patient's characteristics and pathology (concomitant diseases, extent of lesions, treatment history) and the specialty (adverse effects, cumulative dose). In psoriasis it may be necessary to use different lines of treatment because psoriasis is a lifetime disease. Side effects of systemic treatments such as biotherapy, cyclosporine, methotrexate, synthetic retinoids, and also phototherapy (PUVA and UVB) are cumulative over time. A course of spa treatment should allow a respite before resorting to other systemic therapy.

However, the spa dermatology still suffers from a lack of large-scale evaluation and especially an objective assessment using reliable methodologies that limit bias. This is the purpose of this study.

There are no randomized controlled multicenter clinical trials evaluating spa treatment for psoriasis, although an Italian non-randomized study included a few dozen patients and confirmed the clinical benefit of the treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Both sexes, over 18 years of age, patients with plaque psoriasis for more than one year diagnosed by a dermatologist
  • Stable treatment in the last 6 months
  • DLQI score > 10
  • patients volunteering for spa treatment within 6 weeks
  • consenting to participate to the study with informed consent form signed after appropriate information
  • Affiliation to the French social security system or equivalent

排除标准

  • Pregnancy, parturient or breast feeding
  • Psychiatric illness or social situation that would preclude study compliance
  • Refusal of consent
  • Refusal of spa treatment
  • Contra-indication to spa treatment
  • Phototherapy in the last 3 months
  • Guttate, pustular or erythrodermic psoriasis Isolated nail psoriasis
  • Spa therapy in the past year
  • Person deprived of liberty or under legal guardianship

结局指标

主要结局

Dermatology Quality of Life Index (DQLI)

时间窗: 4 ½ months after randomisation

proportion of patients with a score ≤ 10 at 4½ months in each arm of the study, spa treatment versus usual care.

次要结局

  • Specific Quality Of Life(4 1/2, 6, 9 and 12 months after randomisation)
  • Global Quality Of Life(4 1/2, 6, 9 and 12 months after randomisation)
  • Clinical benefit of the psoriasis(4 1/2, 6, 9 and 12 months after randomisation)
  • pain and pruritus(4 1/2, 6, 9 and 12 months after randomisation)
  • Treatment follow up(4 1/2, 6, 9 and 12 months after randomisation)
  • patient's examination(4 1/2, 6, 9 and 12 months after randomisation)
  • Safety evaluation(4 1/2, 6, 9 and 12 months after randomisation)
  • Stress evaluation(4 1/2, 6, 9 and 12 months after randomisatio)
  • Long term evaluation(12 months)

研究者

发起方
Association Francaise pour la Recherche Thermale
申办方类型
Other
责任方
Sponsor

研究点 (10)

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