NCT06735911招募中不适用
Assessment at 4.5 Months of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis (BAREGES)
Thermes de Bareges4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis
研究概览
简要总结
Evaluation of the effect of a dermatology-oriented spa therapy at 4.5 months on the quality of life of patients suffering from psoriasis
详细描述
BAREGES is a:
prospective, before/after, cohort follow-up study with repeated measurements monocentric study with the dispensation of a 3-week dermatolgy-oriented spa therapy in Barèges
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age ≥ 18 years Patient with psoriasis Stable treatment in the last 6 months. DLQI > 10 Patient presenting an indication for thermal treatment focused on dermatology (possible dual orientation).
- •Patient affiliated to the social security system or such a system Available for an 18-day spa treatment and a 9-month follow-up For women of childbearing age: effective contraception Patient information and informed consent signature
排除标准
- •Contraindication to thermal treatment (e.g., ongoing chemotherapy/radiotherapy, uncontrolled progressive neoplasia, progressive heart disease, etc., according to the investigator's assessment) Predictable intolerance to thermal treatments (intolerance to heat, baths, etc.) Patient who has already undergone a dermatology-oriented spa treatment within the current thermal season Subject already included in an interventional clinical research protocol Persons referred to in articles L1121-5 to L1121-8 of the "Code de la Santé Publique" (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)
结局指标
主要结局
To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis
时间窗: 4.5 months
Percentage of patients with a score ≤ 10 (moderate impact) on the Dermatology Life Quality Index (DLQI) questionnaire at 4.5 months.The DLQI score is between 0 and 30 where a high score indicates a significant impairment of quality of life.
次要结局
- To evaluate the effect of a complete thermal treatment (low impact) for a dermatological indication on the quality of life of patients with psoriasis at 4.5 months, taking into account all the care provided(4.5 months)
- To evaluate dermatology-specific quality of life (quantitative DLQI score)(4.5 and 9 months)
- To evaluate overall quality of life using the EQ-5D-5L questionnaire.(4.5 and 9 months)
- To evaluate the clinical improvement of psoriasis in the short and medium term.(4.5 and 9 months)
- To evaluate pain and pruritus.(4.5 and 9 months)
- Physician/Patient perception : The physician's and patient's opinion will be requested to assess the perceived benefit of the treatment.(4.5 and 9 months)
- Medication consumption(4.5 and 9 months)
- Evolution of the general clinical criteria : Body Mass Index (BMI)(4.5 and 9 months)
- Evolution of the general clinical criteria : systolic blood pressure(4.5 and 9 months)
- Evolution of the general clinical criteria : diastolic blood pressure(4.5 and 9 months)
- Evolution of the general clinical criteria : heart rate(4.5 and 9 months)
- Evaluation of the use of care related or not to psoriasis at 4.5 and 9 months(4.5 and 9 months)
- Evaluation of compliance with the spa therapy(3 weeks)
研究者
研究点 (4)
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