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关于使用PROXERA PSOMED 20和PROXERA PSOMED 40医疗器械治疗斑块型银屑病和非脓疱型掌跖银屑病的临床研究 (PASI)

2026年7月26日 更新者：ICIM International S.r.l.

评估医疗设备PROXERA PSOMED 20减少银屑病斑块及医疗设备PROXERA PSOMED 40减少斑块型银屑病患者非脓疱性掌跖银屑病皮损的有效性与安全性：一项赞助性、干预性、单中心、随机、单盲、患者内对照研究（PASI）

这项单中心介入性研究旨在评估两种CE认证的局部医疗器械的疗效和安全性：PROXERA PSOMED 20正在非掌跖斑块状银屑病患者中进行研究，而PROXERA PSOMED 40正在非脓疱性掌跖银屑病患者中进行研究。

本研究旨在确定，与同一参与者未治疗的对侧对照区域相比，使用指定医疗器械治疗目标区域是否能带来更大的临床改善。对于PROXERA PSOMED 20，主要评估在治疗4周后进行。对于PROXERA PSOMED 40，主要评估在治疗8周后进行。

次要目标包括安全性评估、局部耐受性、银屑病总体进展、其对生活质量的影响，以及目标区域局部疾病活动的其他参数。参与者将每天一次将指定的研究器械应用于选定的目标区域，在预定访视时接受临床评估，并在整个研究期间提供安全性和耐受性信息。

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

35

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Paolo Amerio, Professore Ordinario
  • 电话号码：+ 39 0871358032
  • 邮箱：paolo.amerio@unich.it

学习地点

  • 意大利
    • Italia
      • Chieti、Italia、意大利、66100
        • 招聘中
        • Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

PROXERA PSOMED 20 - 标准化乳霜，20%尿素

  • 诊断为斑块状银屑病（非掌跖部位）至少1年 PROXERA PSOMED 40 - 强效去角质凝胶，40%尿素
  • 诊断为非脓疱性掌跖银屑病至少1年

共同纳入标准：

  • 年龄18-65岁
  • 根据以下标准为“轻度”银屑病严重程度：
  • 银屑病面积严重程度指数（PASI）<10
  • 皮肤病生活质量指数（DLQI）<10
  • 体表面积（BSA）<10

排除标准：

  • 产品不耐受
  • 同时使用系统性免疫调节药物（如甲氨蝶呤、环孢素、阿普斯特）治疗
  • 同时使用生物制剂治疗，如抗TNFα、抗IL17或抗IL23。
  • 同时使用局部皮质类固醇（TCS）、局部钙调神经磷酸酶抑制剂（TCI）、维生素D类似物及其组合进行局部治疗。
  • 孕妇或哺乳期妇女

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：患者内使用PROXERA PSOMED 20治疗
单组、随机、单盲、患者自身对照研究组。 根据诊断分配参与者治疗：非掌跖斑块型银屑病参与者在目标斑块上每日一次使用PROXERA PSOMED 20，持续4周；而非脓疱性掌跖银屑病参与者在目标手掌或足底区域每日一次使用PROXERA PSOMED 40，持续8周。 在两个队列中，可比较的对侧目标区域保持未治疗作为对照。 对于PROXERA PSOMED 40，每14天中断治疗3天。
设备：PROXERA PSOMED 20 乳膏；PROXERA PSOMED 40 凝胶

Proxera Psomed 20：外用医疗器械，乳膏剂型，含20%尿素，包装为200毫升管装。 由参与者根据指尖单位规则，每日在同一时间自行涂抹于选定的目标斑块，持续4周。 对侧可比较目标区域保持未处理作为对照。

Proxera Psomed 40：外用医疗器械，凝胶剂型，含40%尿素，包装为100毫升管装。 由参与者根据指尖单位规则，每日在同一时间自行涂抹于选定的目标手掌或足底区域，持续8周。 每14天中断治疗3天。 对侧可比较目标区域保持未处理作为对照。

其他名称：
  • PROXERA PSOMED 40 - 强效去角质凝胶，含40%尿素
  • PROXERA PSOMED 20 - 正常化乳霜，20% 尿素
实验性的：PROXERA PSOMED 40 患者内治疗
患有非脓疱性掌跖银屑病的参与者每天在同一时间，将PROXERA PSOMED 40涂抹于一只目标手掌或足底区域，持续8周。 剂量按照指尖单位规则进行涂抹。 对侧可比较的目标区域保持不治疗，作为对照。 治疗每14天中断3天。
设备：PROXERA PSOMED 20 乳膏；PROXERA PSOMED 40 凝胶

Proxera Psomed 20：外用医疗器械，乳膏剂型，含20%尿素，包装为200毫升管装。 由参与者根据指尖单位规则，每日在同一时间自行涂抹于选定的目标斑块，持续4周。 对侧可比较目标区域保持未处理作为对照。

Proxera Psomed 40：外用医疗器械，凝胶剂型，含40%尿素，包装为100毫升管装。 由参与者根据指尖单位规则，每日在同一时间自行涂抹于选定的目标手掌或足底区域，持续8周。 每14天中断治疗3天。 对侧可比较目标区域保持未处理作为对照。

其他名称：
  • PROXERA PSOMED 40 - 强效去角质凝胶，含40%尿素
  • PROXERA PSOMED 20 - 正常化乳霜，20% 尿素

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4
大体时间：Baseline to Week 4 (end of treatment)
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 4 in the treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8
大体时间：Baseline to Week 8 (end of treatment)
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the primary analysis compares the change from baseline to Week 8 in the treated target area with the change in the contralateral untreated control area.
Baseline to Week 8 (end of treatment)

次要结果测量

结果测量
措施说明
大体时间
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8
大体时间：Baseline to Week 8 (4 weeks after the end of treatment)
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 8 in the treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 12
大体时间：Baseline to Week 12 (4 weeks after the end of treatment)
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the outcome compares the change from baseline to Week 12 in the treated target area with the change in the contralateral untreated control area.
Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
大体时间：Baseline to Week 4 (end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 4 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment is used to determine whether changes observed in the target plaque occur independently of, or in parallel with, changes in overall psoriasis severity.
Baseline to Week 4 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
大体时间：Baseline to Week 8 (end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment is used to determine whether changes observed in the target palm or sole area occur independently of, or in parallel with, changes in overall psoriasis severity.
Baseline to Week 8 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
大体时间：Baseline to Week 8 (4 weeks after the end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
大体时间：Baseline to Week 12 (4 weeks after the end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 12 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
大体时间：Baseline to Week 4 (end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 4 in participants treated with PROXERA PSOMED 20.
Baseline to Week 4 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
大体时间：Baseline to Week 8 (end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 40.
Baseline to Week 8 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
大体时间：Baseline to Week 8 (4 weeks after the end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
大体时间：Baseline to Week 12 (4 weeks after the end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 12 in participants treated with PROXERA PSOMED 40, 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 4
大体时间：Baseline to Week 4 (end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 4 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 8
大体时间：Baseline to Week 8 (end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area.
Baseline to Week 8 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 8
大体时间：Baseline to Week 8 (4 weeks after the end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 12
大体时间：Baseline to Week 12 (4 weeks after the end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 12 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area, 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 4
大体时间：Baseline to Week 4 (end of treatment)
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 4 between the two target plaques in participants treated with PROXERA PSOMED 20.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 8
大体时间：Baseline to Week 8 (4 weeks after the end of treatment)
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 8 between the two target plaques in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 20 Cohort
大体时间：From first application through Week 8
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
From first application through Week 8
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 40 Cohort
大体时间：From first application through Week 12
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
From first application through Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ICIM International S.r.l.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月30日

初级完成 (估计的)

2026年11月25日

研究完成 (估计的)

2026年12月23日

研究注册日期

首次提交

2026年4月16日

首先提交符合 QC 标准的

2026年4月16日

首次发布 (实际的)

2026年4月22日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月26日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • Id 286

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

单个参与者的数据不会公开提供。 研究数据是保密的，由申办方所有。 参与者数据的处理遵循适用的数据保护法律，并进行编码以保护机密性。 任何研究结果的发表都需根据研究发表政策，经过申办方和主要研究者的审查和批准。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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