NCT01529320已完成1 期
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
Fundacion IMIM1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.
研究概览
简要总结
Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects ≥18 years old.
- •Subjects with a history of diagnosis of sensitization to Nickel sulphate.
- •Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test.
- •Skin Phototype II-III.
- •Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study.
- •Written informed consent prior to inclusion.
- •Able and willing to comply with protocol procedures and to follow the investigator's instructions.
- •Criteria for treatment initiation: At day 7, before starting treatment, subjects must meet the inclusion criteria and all the following criteria: ≥ 3 VAS and eczema intensity of (+ +) or (+++) according to ICDRG scale.
排除标准
- •Active cutaneous disease causing itch (active eczema, urticaria or insect bites)
- •Active systemic disease that may induce itch (hepatic or renal disease).
- •Active psychiatric disease that could interfere with symptom assessment.
- •Treatment with drugs inducing itch.
- •Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test.
- •Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors.
- •Active skin disease in the back that may interfere with the assessment of response to topical application of allergen
- •Pregnancy or lactation
- •Subjects with contraindications specified in Summary of Product Characteristics (SPC).
研究组 & 干预措施
Adventan® (metilprednisolona aceponato 0,1%)
Experimental
干预措施: Adventan® (methylprednisolone aceponate 0,1%) (Drug)
结局指标
主要结局
Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.
时间窗: 5 days
Time to Itch Relief is defined as the time needed to reach a 30% decrease of the maximum VAS (Visual Analogue Scale used for self-assessment of itch by the volunteers) recorded after the start of treatment.
次要结局
- Erythema intensity by colorimetry.(5 days)
- Eczema intensity by planimetric morphology (ICDRG scale)(5 days)
- VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)(5 days)
研究者
Ana Maria Gimenez Arnau
MD
Fundacion IMIM
研究点 (1)
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