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临床试验/NCT02489643
NCT02489643已完成不适用

Role of an Individualized Medical Training in Improving Efficacy and Adherence to a 4-week Treatment With Calcipotriol and Betamethasone Dipropionate Gel for Mild-to-moderate Plaque Psoriasis

Catholic University of the Sacred Heart0 个研究点目标入组 60 人开始时间: 2014年5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
60
主要终点
Efficacy as measured by PASI improvement

研究概览

简要总结

The aim of the study will be to evaluate the impact of this individualized practical training on efficacy (evaluated by Psoriasis Area and Severity Index (PASI) and Body Surface Area (BSA) score performed by a physician blinded to the study groups) and adherence (calculated as days wherein gel was applied and as BSA/weight of gel applied rate) to a 4 week long treatment with dovobet gel. On the other hand, the investigators will evaluate in both groups as demographic (as sex, age, job,..) or disease (as severity, duration, impact of quality of life,..) characteristics influence the adherence to 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
Treatment
盲法
Single (Outcomes Assessor)

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

  • Diagnosis of psoriasis will be maid mainly on clinical findings. If doubts, a skin sample will be obtained and evaluated by histopathological examination.

排除标准

  • Patients with palmoplantar, scalp, inverse, erythrodermic, guttate, pustular psoriasis will be excluded.

结局指标

主要结局

Efficacy as measured by PASI improvement

时间窗: 1 month

Efficacy as measured by BSA improvement

时间窗: 1 month

次要结局

  • Adherence as measured by days wherein gel was applied(1 month)
  • Adherence as measured by BSA/weight of gel applied rate(1 month)

研究者

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

Giacomo Caldarola

MD, PhD

Catholic University of the Sacred Heart

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