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临床试验/NCT07844772
NCT07844772招募中不适用

Evaluation of the Association of Serum Substance P Levels With Neuropathic Pain, Central Sensitization, Disease Severity, and Quality of Life Across Different Treatment Groups in Patients With Chronic Plaque Psoriasis

Istanbul Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Association Between Serum Substance P Levels and DN4 Score

研究概览

简要总结

The goal of this observational study is to better understand whether blood levels of Substance P are related to pain, itching, altered pain sensations, central sensitization, psoriasis severity, and quality of life in adults with chronic plaque psoriasis.

The main questions this study aims to answer are:

Are serum Substance P levels associated with neuropathic pain features, central sensitization, psoriasis severity, pain, itching, and quality of life? Do serum Substance P levels and these clinical features differ among patients receiving different psoriasis treatments?

Researchers will compare three groups of patients: those receiving IL-17 inhibitor treatment, those receiving conventional systemic treatment with methotrexate or acitretin, and those receiving topical treatment only or no current treatment.

Participants will:

Have their psoriasis severity assessed and complete questionnaires about pain, itching, central sensitization, and quality of life.

Undergo a neurological examination. Participants who report pain will also be evaluated for neuropathic pain features using the DN4 questionnaire.

Provide a blood sample for measurement of serum Substance P and routine laboratory tests.

Undergo electromyography and nerve conduction studies if peripheral neuropathy is suspected during the neurological evaluation.

No treatment will be assigned or changed as part of this study.

详细描述

Psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by complex interactions between immune pathways, cutaneous inflammation, and the nervous system. In addition to visible skin lesions, patients may experience pruritus, pain, burning, tingling, and other sensory complaints that can substantially impair quality of life. Increasing evidence suggests that neuroimmune mechanisms may contribute to these symptoms. Substance P, a neuropeptide involved in neurogenic inflammation, nociception, and pruritus, may represent one of the mediators linking cutaneous inflammation with sensory symptoms in psoriasis. The IL-17 pathway may also interact with neuroimmune mechanisms involved in pain and pruritus.

This single-center, cross-sectional, observational study aims to investigate the relationship between serum Substance P levels and clinical features including neuropathic pain characteristics, central sensitization, psoriasis severity, pain intensity, pruritus intensity, and dermatology-related quality of life in adults with chronic plaque psoriasis. The study will also explore whether serum Substance P levels and clinical characteristics differ according to the patients current treatment approach.

Approximately 100 patients with chronic plaque psoriasis will be enrolled and evaluated in three treatment groups: patients receiving IL-17 inhibitor therapy, patients receiving conventional systemic therapy such as methotrexate or acitretin, and patients receiving topical therapy only or no current treatment. Treatment history and duration of current therapy will also be recorded.

Psoriasis severity will be assessed using the Psoriasis Area and Severity Index (PASI), and quality of life will be evaluated using the Dermatology Life Quality Index (DLQI). Pain and pruritus intensity will be recorded using Numeric Rating Scales (NRS), and central sensitization symptoms will be evaluated using the Central Sensitization Inventory (CSI).

The presence and localization of pain will be recorded, including whether the pain is associated with psoriatic plaques. In participants reporting pain, neuropathic pain characteristics will be assessed using the Douleur Neuropathique 4 Questions (DN4). DN4 scores will be recorded both as total scores and according to the validated cutoff, with scores of 4 or higher considered positive for neuropathic pain features. Participants without pain will not undergo DN4 assessment.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
横断面

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

  • Age ≥18 years
  • Diagnosis of chronic plaque psoriasis
  • Ability and willingness to provide written informed consent
  • For the IL-17 inhibitor group: current treatment with an IL-17 inhibitor for at least 8 weeks
  • For the conventional systemic therapy group: current treatment with methotrexate or acitretin for at least 6 weeks
  • For the topical therapy/treatment-naive group: topical therapy only or no previous treatment, with no systemic therapy, biologic therapy, or phototherapy within the previous 6 months

排除标准

  • Known diabetes mellitus, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL
  • Vitamin B12 level <200 pg/mL
  • Known peripheral neuropathy or peripheral neuropathy detected during neurological evaluation and/or electromyography
  • Neuropathy related to uremia or thyroid disease
  • Chronic renal failure or chronic liver failure
  • Active infection
  • Active malignancy
  • Active inflammatory arthritis in patients with psoriatic arthritis
  • Pregnancy or breastfeeding
  • Chronic heavy alcohol use

研究组 & 干预措施

IL-17 Inhibitor Group

Patients with chronic plaque psoriasis receiving an IL-17 inhibitor as part of routine clinical care. Participants are included according to their existing treatment, and no treatment is assigned or modified by the study.

干预措施: IL-17 Inhibitor Therapy (Biological)

Conventional Systemic Therapy Group

Patients with chronic plaque psoriasis receiving conventional systemic treatment with methotrexate or acitretin as part of routine clinical care. No treatment is assigned or modified by the study.

干预措施: Conventional Systemic Therapy (Drug)

Topical Therapy or Treatment-Naive Group

Patients with chronic plaque psoriasis receiving topical therapy only or who have not yet received any treatment for psoriasis. Participants in this group have not received systemic therapy, biologic therapy, or phototherapy within the previous 6 months.

结局指标

主要结局

Association Between Serum Substance P Levels and DN4 Score

时间窗: Baseline (Day 1)

The association between serum Substance P concentration measured by ELISA and the total Douleur Neuropathique 4 Questions (DN4) score will be evaluated among participants who report pain and undergo DN4 assessment. DN4 scores range from 0 to 10, with scores ≥4 considered positive for neuropathic pain features.

Association Between Serum Substance P Levels and Central Sensitization Inventory Score

时间窗: Baseline (Day 1)

The association between serum Substance P concentration and the Central Sensitization Inventory (CSI) Part A total score will be evaluated. Part A consists of 25 items, with total scores ranging from 0 to 100. Higher scores indicate a greater burden of symptoms associated with central sensitization.

Association Between Serum Substance P Levels and Psoriasis Severity

时间窗: Baseline (Day 1)

The association between serum Substance P concentration and psoriasis severity measured by the Psoriasis Area and Severity Index (PASI) will be evaluated. PASI ranges from 0 to 72, with higher scores indicating greater disease severity.

Association Between Serum Substance P Levels and Pain Intensity

时间窗: Baseline (Day 1)

The association between serum Substance P concentration and pain intensity measured using a 0-10 Numeric Rating Scale (NRS) will be evaluated, with higher scores indicating greater pain intensity.

Association Between Serum Substance P Levels and Pruritus Intensity

时间窗: Baseline (Day 1)

The association between serum Substance P concentration and pruritus intensity measured using a 0-10 Numeric Rating Scale (NRS) will be evaluated, with higher scores indicating greater pruritus intensity.

Association Between Serum Substance P Levels and Dermatology-Related Quality of Life

时间窗: Baseline (Day 1)

The association between serum Substance P concentration and the Dermatology Life Quality Index (DLQI) score will be evaluated. DLQI ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

次要结局

  • Differences in Serum Substance P Levels Across Treatment Groups(Baseline (Day 1))
  • Psoriasis Area and Severity Index (PASI) Score Across Treatment Groups(Baseline (Day 1))
  • Central Sensitization Inventory (CSI) Score Across Treatment Groups(Baseline (Day 1))
  • Dermatology Life Quality Index (DLQI) Score Across Treatment Groups(Baseline (Day 1))
  • Pain Numeric Rating Scale (NRS) Score Across Treatment Groups(Baseline (Day 1))
  • Pruritus Numeric Rating Scale (NRS) Score Across Treatment Groups(Baseline (Day 1))
  • Douleur Neuropathique 4 Questions (DN4) Score Across Treatment Groups(Baseline (Day 1))

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
其他政府机构
责任方
主要研究者
主要研究者

Yasemin Dündar Şahin

Dermatology resident physician

Istanbul Training and Research Hospital

研究点 (1)

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标识符

NCT 编号
NCT07844772
其他研究编号
IstanbulTRH-DERM-PSO-SP-2026

日期

首次提交
(13天前)
首次发布
(前天)
主要完成日期
(2个月后)
研究完成日期
(3个月后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否

Individual participant data will not be shared because there is currently no predefined plan or ethical approval for sharing de-identified participant-level data with researchers outside the study team. Study findings will be reported in aggregate form in scientific outputs.

是否有结果
否

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