An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 29
- 主要终点
- Pruritus clinical criterion
研究概览
简要总结
To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis
详细描述
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To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis in the:
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Improvement of pruritus
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Improvement of psoriasis severity
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Improvement of quality of life
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Change of pruritus and psoriasis biological markers
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Intake/application of treatments and skin care products for psoriasis and pruritus management, evaluated during a follow-up period
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To assess the time to pruritus relapse evaluated in subjects with pruritic plaque psoriasis, during the period following the Avène hydrotherapy (for the hydrotherapy group only)
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To assess the global efficacy of the Avène hydrotherapy in pruritic plaque psoriasis, according to subjects' and investigators' opinion (for the hydrotherapy group only)
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To assess the global cutaneous tolerance of the Avène hydrotherapy in subjects with pruritic plaque psoriasis (for the hydrotherapy group only)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •Subject with plaque psoriasis
- •Subject with moderate to very severe chronic pruritus whose NRS score ≥ 4, (on a scale ranged from 0 to 10)
- •Subject with chronic pruritus, i.e. for at least 6 weeks, due to plaque psoriasis
排除标准
- •Subject with erythrodermic psoriasis, pustular psoriasis or palmoplantar keratoderma
- •Subject with any other type of pruritus, not related to plaque psoriasis
- •Subject with an acute, chronic or progressive disease other than plaque psoriasis which could be the origin of the pruritus
- •Biotherapy, Phototherapy or PUVAtherapy treatment
- •Psoriasis treatment by LASER
- •Systemic or topical treatment taken/applied for psoriasis or pruritus management established or modified since the selection visit or planned to be established or modified between the inclusion visit and the end of the hydrotherapy
结局指标
主要结局
Pruritus clinical criterion
时间窗: Day18
Pruritus intensity assessed by the subject on the NRS from 0 to 10
次要结局
- Pruritus clinical criterion(Day202)
- Quality of life criterion(Day1, Day18, Day111 and Day202)
- Psoriasis clinical criterion(Day1, Day18, Day111 and Day202)
- Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)(Day1, Day18, Day111 and Day202)
- Hydrotherapy criterion(Day18)