Evaluation of the Efficacy and Safety of the Medical Device PROXERA PSOMED 20 in Reducing Psoriatic Plaques and of the Medical Device PROXERA PSOMED 40 in Reducing Non-pustulous Palmoplantar Psoriasis Flaw in Patients With Plaque Psoriasis: a Sponsored, Interventional, Single-center, Randomized, Single-blind, Intra-patient Controlled Study (PASI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Proxera Psomed 20: Change From Baseline in Target Lesion Score at Week 4
研究概览
简要总结
This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 is being studied in participants with non-pustular palmoplantar psoriasis.
The study aims to determine whether treating a target area with the assigned medical device leads to greater clinical improvement compared to the untreated contralateral control area in the same participant. For PROXERA PSOMED 20, the primary assessment is performed after 4 weeks of treatment. For PROXERA PSOMED 40, the primary assessment is performed after 8 weeks of treatment.
Secondary objectives include the assessment of safety, local tolerability, overall psoriasis progress, its impact on quality of life, and additional parameters of local disease activity at the target areas. Participants will apply the assigned study device once daily to the selected target area, undergo clinical assessments at scheduled visits, and provide safety and tolerability information throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants are informed which target area receives active treatment for self-application purposes. The outcome assessor/evaluator remains blinded to treatment allocation during study assessments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROXERA PSOMED 20 - normalizing cream, 20% urea
- •Diagnosis of plaque psoriasis (not palmoplantar) for at least 1 year PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea
- •Diagnosis of non-pustular palmoplantar psoriasis for at least 1 year
- •Common inclusion criteria:
- •Age 18-65 years
- •"Mild" psoriasis severity according to:
- •Psoriasis Area Severity Index (PASI) <10
- •Dermatologic Life Quality Index (DLQI) <10
- •Body Surface Area (BSA) <10
排除标准
- •Product intolerance
- •Concomitant therapy with systemic immunomodulatory drugs (e.g., methotrexate, cyclosporine, apremilast)
- •Concomitant therapy with biologic drugs such as anti-TNFα, anti-IL17, or anti-IL
- •Concomitant topical therapy with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations.
- •Pregnant or breastfeeding women
研究组 & 干预措施
Intra-patient Treatment With PROXERA PSOMED 20
Single-group, randomized, single-blind, intra-patient controlled study arm. Participants are assigned to treatment according to diagnosis: participants with non-palmoplantar plaque psoriasis receive PROXERA PSOMED 20 once daily for 4 weeks on one target plaque, while participants with non-pustular palmoplantar psoriasis receive PROXERA PSOMED 40 once daily for 8 weeks on one target palm or sole area. In both cohorts, a comparable contralateral target area remains untreated as control. For PROXERA PSOMED 40, treatment is interrupted for 3 days every 14 days.
干预措施: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel (Device)
Intra-patient Treatment With PROXERA PSOMED 40
Participants with non-pustular palmoplantar psoriasis self-apply PROXERA PSOMED 40 once daily at the same time of day to one target palm or sole area for 8 weeks. The dose is applied according to the fingertip unit rule. A comparable contralateral target area remains untreated as control. Treatment is interrupted for 3 days every 14 days.
干预措施: PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel (Device)
结局指标
主要结局
Proxera Psomed 20: Change From Baseline in Target Lesion Score at Week 4
时间窗: Proxera Psomed 20: From baseline to end of treatment (4 weeks)
Proxera Psomed 20: Target Lesion Score (TLS) is a semi-quantitative clinical score used to assess the severity of a representative psoriatic plaque. Three plaque characteristics are evaluated separately: erythema, induration (thickness), and scaling. Each item is scored from 0 to 4, and the total TLS ranges from 0 to 12, with higher scores indicating more severe disease. The primary analysis compares the change from baseline to Week 4 in the treated target plaque versus the untreated contralateral control area.
Proxera Psomed 40: Change From Baseline in Modified Palmoplantar Psoriasis Area and Severity Index at Week 8
时间窗: Proxera Psomed 40: From baseline to end of treatment (8 weeks)
Proxera Psomed 40: Modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) is a clinical score used to assess the severity of non-pustular palmoplantar psoriasis. The score evaluates erythema, induration, scaling, and extent of involvement in the palmoplantar target area. Higher scores indicate more severe disease. The primary analysis compares the change from baseline to Week 8 in the treated target palm or sole area versus the untreated contralateral control area.
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4
时间窗: 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.
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8
时间窗: 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.
次要结局
- Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Baseline to Week 4 (end of treatment))
- Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 8(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(From first application through Week 8)
- Number of Participants With One or More Adverse Events in the PROXERA PSOMED 40 Cohort(From first application through Week 12)