[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657939":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":58,"studyPopulation":59,"armGroups":60,"interventions":74,"overallOfficials":85,"centralContacts":89,"locations":95,"responsibleParty":110,"collaborators":55,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":55,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":55,"enrollmentInfo":122,"targetDuration":55,"studyType":125,"phases":55,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":97,"whyStopped":55,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Istanbul Training and Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":50},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Association Between Serum Substance P Levels and DN4 Score","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.","Baseline (Day 1)",{"measure":14,"description":15,"timeFrame":12},"Association Between Serum Substance P Levels and Central Sensitization Inventory Score","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.",{"measure":17,"description":18,"timeFrame":12},"Association Between Serum Substance P Levels and Psoriasis Severity","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.",{"measure":20,"description":21,"timeFrame":12},"Association Between Serum Substance P Levels and Pain Intensity","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.",{"measure":23,"description":24,"timeFrame":12},"Association Between Serum Substance P Levels and Pruritus Intensity","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.",{"measure":26,"description":27,"timeFrame":12},"Association Between Serum Substance P Levels and Dermatology-Related Quality of Life","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.",[29,32,35,38,41,44,47],{"measure":30,"description":31,"timeFrame":12},"Differences in Serum Substance P Levels Across Treatment Groups","Serum Substance P concentrations will be compared among participants receiving IL-17 inhibitor therapy, conventional systemic therapy with methotrexate or acitretin, and topical therapy only or no previous\u002Fcurrent systemic treatment according to the study group definitions.",{"measure":33,"description":34,"timeFrame":12},"Psoriasis Area and Severity Index (PASI) Score Across Treatment Groups","The Psoriasis Area and Severity Index (PASI) total score will be compared across the three predefined treatment groups. Scores range from 0 to 72, with higher scores indicating greater psoriasis severity.",{"measure":36,"description":37,"timeFrame":12},"Central Sensitization Inventory (CSI) Score Across Treatment Groups","The Central Sensitization Inventory (CSI) Part A total score will be compared across the three predefined treatment groups. 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.",{"measure":39,"description":40,"timeFrame":12},"Dermatology Life Quality Index (DLQI) Score Across Treatment Groups","The Dermatology Life Quality Index (DLQI) total score will be compared across the three predefined treatment groups. Total scores range from 0 to 30, with higher scores indicating greater impairment of dermatology-related quality of life.",{"measure":42,"description":43,"timeFrame":12},"Pain Numeric Rating Scale (NRS) Score Across Treatment Groups","Pain intensity assessed using the Numeric Rating Scale (NRS) will be compared across the three predefined treatment groups. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.",{"measure":45,"description":46,"timeFrame":12},"Pruritus Numeric Rating Scale (NRS) Score Across Treatment Groups","Pruritus intensity assessed using the Numeric Rating Scale (NRS) will be compared across the three predefined treatment groups. Scores range from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus intensity.",{"measure":48,"description":49,"timeFrame":12},"Douleur Neuropathique 4 Questions (DN4) Score Across Treatment Groups","The Douleur Neuropathique 4 Questions (DN4) total score will be compared across the three predefined treatment groups among participants who report pain and undergo DN4 assessment. Total scores range from 0 to 10, with higher scores indicating a greater number of neuropathic pain features. A score of 4 or higher indicates a positive screening result for neuropathic pain.",[51],{"measure":52,"description":53,"timeFrame":12},"Neurological Sensory Symptoms and Sensory Examination Findings","The presence of sensory symptoms including burning, stinging, electric shock-like sensations, tingling, numbness, pins and needles, pain associated with itching, pain evoked by touch, and sensitivity to heat or cold will be recorded. Sensory examination findings including vibration sensation, pinprick sensation, allodynia, and hyperalgesia will also be documented during the neurological examination. The frequency and distribution of these symptoms and examination findings will be evaluated.",{"allocation":55,"interventionModel":55,"interventionModelDescription":55,"primaryPurpose":55,"observationalModel":56,"timePerspective":57,"maskingInfo":55},null,"COHORT","CROSS_SECTIONAL","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.\n\nThis 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.\n\nApproximately 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.\n\nPsoriasis 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).\n\nThe 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.\n\nAll participants will undergo a standardized neurological evaluation in collaboration with the Neurology Department. Neurological examination will include assessment for findings suggestive of peripheral neuropathy. Electromyography and nerve conduction studies will be performed when peripheral neuropathy is clinically suspected, and participants with confirmed peripheral neuropathy will be excluded from the relevant study analyses according to the study protocol.\n\nVenous blood samples will be obtained for measurement of serum Substance P concentrations using an enzyme-linked immunosorbent assay (ELISA). Laboratory assessments will also include parameters used to identify potential causes of peripheral neuropathy or relevant systemic confounders, including glycated hemoglobin (HbA1c), fasting glucose, vitamin B12, renal and liver function tests, thyroid function tests, complete blood count, erythrocyte sedimentation rate, and C-reactive protein, as clinically appropriate.\n\nThe primary analyses will examine the associations between serum Substance P concentrations and clinical measures of neuropathic pain features, central sensitization, psoriasis severity, pain, pruritus, and quality of life. Comparisons across the three treatment groups will also be performed to explore whether neuroimmune and clinical profiles differ according to treatment exposure.","Adults with chronic plaque psoriasis who are followed at the Dermatology Department of Istanbul Training and Research Hospital and meet the study eligibility criteria will be included. Participants will be classified into three predefined groups according to their current psoriasis treatment: IL-17 inhibitor therapy, conventional systemic therapy with methotrexate or acitretin, and topical therapy only or treatment-naive. Participants will undergo clinical, patient-reported, laboratory, and neurological assessments during a single cross-sectional study period.",[61,66,71],{"label":62,"type":55,"description":63,"interventionNames":64},"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.",[65],"Biological: IL-17 Inhibitor Therapy",{"label":67,"type":55,"description":68,"interventionNames":69},"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.",[70],"Drug: Conventional Systemic Therapy",{"label":72,"type":55,"description":73,"interventionNames":55},"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.",[75,80],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":55},"BIOLOGICAL","IL-17 Inhibitor Therapy","Exposure to IL-17 inhibitor therapy prescribed as part of routine clinical care for chronic plaque psoriasis. Treatment is not assigned, initiated, or modified by the study. Participants are classified according to their current treatment at the time of study assessment.",[62],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":55},"DRUG","Conventional Systemic Therapy","Exposure to conventional systemic therapy with methotrexate or acitretin prescribed as part of routine clinical care for chronic plaque psoriasis. Treatment is not assigned, initiated, or modified by the study.",[67],[86],{"name":87,"affiliation":5,"role":88},"Vildan Manav","STUDY_CHAIR",[90],{"name":91,"role":92,"phone":93,"phoneExt":55,"email":94},"Yasemin Dündar Şahin, Dermatology resident physician","CONTACT","+905394254565","yasemindundar97@gmail.com",[96],{"facility":5,"status":97,"city":98,"state":98,"zip":99,"country":100,"countryCode":55,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"RECRUITING","Istanbul","34098","Turkey (Türkiye)",{"type":102,"coordinates":103},"Point",[104,105],28.94966,41.01384,{"lat":105,"lon":104},[108],{"name":109,"role":92,"phone":93,"phoneExt":55,"email":94},"Yasemin Dündar Şahin",{"type":111,"investigatorFullName":109,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"PRINCIPAL_INVESTIGATOR","Dermatology resident physician","100657939","serum-substance-p-neuropathic-pain-and-central-sensitization-across-treatment-groups-in-chronic-plaque-psoriasis-100657939",false,"NCT07844772","Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis","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","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of chronic plaque psoriasis\n* Ability and willingness to provide written informed consent\n* For the IL-17 inhibitor group: current treatment with an IL-17 inhibitor for at least 8 weeks\n* For the conventional systemic therapy group: current treatment with methotrexate or acitretin for at least 6 weeks\n* For the topical therapy\u002Ftreatment-naive group: topical therapy only or no previous treatment, with no systemic therapy, biologic therapy, or phototherapy within the previous 6 months\n\nExclusion Criteria:\n\n* Known diabetes mellitus, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg\u002FdL\n* Vitamin B12 level \\\u003C200 pg\u002FmL\n* Known peripheral neuropathy or peripheral neuropathy detected during neurological evaluation and\u002For electromyography\n* Neuropathy related to uremia or thyroid disease\n* Chronic renal failure or chronic liver failure\n* Active infection\n* Active malignancy\n* Active inflammatory arthritis in patients with psoriatic arthritis\n* Pregnancy or breastfeeding\n* Chronic heavy alcohol use","ALL","18 Years",{"count":123,"type":124},100,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions this study aims to answer are:\n\nAre 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?\n\nResearchers 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.\n\nParticipants will:\n\nHave their psoriasis severity assessed and complete questionnaires about pain, itching, central sensitization, and quality of life.\n\nUndergo a neurological examination. Participants who report pain will also be evaluated for neuropathic pain features using the DN4 questionnaire.\n\nProvide a blood sample for measurement of serum Substance P and routine laboratory tests.\n\nUndergo electromyography and nerve conduction studies if peripheral neuropathy is suspected during the neurological evaluation.\n\nNo treatment will be assigned or changed as part of this study.",[128],"Chronic Plaque-type Psoriasis",[130,131,132,133,134,135,136],"Central Sensitization","Interleukin-17 Inhibitors","Substance P","Neuropathic Pain","Pain","Pruritus","Quality of Life","2026-09-22",{"date":139,"type":140},"2026-09-28","ACTUAL",{"date":142,"type":140},"2026-06-11",{"date":144,"type":124},"2027-01",{"name":5,"class":6},1]