[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ICIM International S.r.l.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100634916","clinical-study-on-the-medical-devices-proxera-psomed-20-and-proxera-psomed-40-for-the-treatment-of-plaque-psoriasis-and-non-pustular-palmoplantar-psoriasis-100634916",false,"NCT07545902","Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis","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)","PASI","Inclusion Criteria:\n\nPROXERA PSOMED 20 - normalizing cream, 20% urea\n\n* Diagnosis of plaque psoriasis (not palmoplantar) for at least 1 year PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea\n* Diagnosis of non-pustular palmoplantar psoriasis for at least 1 year\n\nCommon inclusion criteria:\n\n* Age 18-65 years\n* \"Mild\" psoriasis severity according to:\n* Psoriasis Area Severity Index (PASI) \\\u003C10\n* Dermatologic Life Quality Index (DLQI) \\\u003C10\n* Body Surface Area (BSA) \\\u003C10\n\nExclusion Criteria:\n\n* Product intolerance\n* Concomitant therapy with systemic immunomodulatory drugs (e.g., methotrexate, cyclosporine, apremilast)\n* Concomitant therapy with biologic drugs such as anti-TNFα, anti-IL17, or anti-IL23.\n* Concomitant topical therapy with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations.\n* Pregnant or breastfeeding women","ALL","18 Years","65 Years",{"count":21,"type":22},35,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThe 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.\n\nSecondary 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.",[28,29],"Plaque Type Psorisis","Non-pustular Palmoplantar Psoriasis",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Plaque Psoriasis","Non-Pustular Palmoplantar Psoriasis","PROXERA PSOMED 20","PROXERA PSOMED 40","Urea","Topical Medical Device","Intra-patient Controlled Study","Randomized Study","Single-Blind Study","Psoriasis Area Severity Index","Target Lesion Score","Dermatologic Life Quality Index","modified Palmoplantar Psoriasis Area Severity Index","Trans Epidermal Water Loss","dermato-capillaroscopy","NOT_YET_RECRUITING","2026-04-16",{"date":49,"type":50},"2026-04-22","ACTUAL",{"date":52,"type":22},"2026-04-28",{"date":54,"type":22},"2026-10-20",{"name":56,"class":57},"ICIM International S.r.l.","INDUSTRY",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":83,"locationsCount":58},"100634926","clinical-study-on-the-medical-device-proxera-psomed-30-for-the-treatment-of-nail-psoriasis-evaluation-of-safety-and-efficacy-100634926","NCT07546032","Clinical Study on the Medical Device PROXERA PSOMED 30 for the Treatment of Nail Psoriasis: Evaluation of Safety and Efficacy","Evaluation of the Safety and Efficacy of the Medical Device PROXERA PSOMED 30 in the Treatment of Nail Psoriasis: a Sponsored, Interventional, Single-center, Randomized, Single-site, Intrapatient Controlled Study (NAPSI)","NAPSI","Inclusion Criteria:\n\n* Diagnosis of Psoriasis\n* Diagnosis of nail psoriasis for at least 6 months (NAPSI ≥ 3)\n* Male or female\n* Age between 18 and 65 years\n* Willingness to participate in the study and signing the informed consent form\n\nExclusion Criteria:\n\n* Known hypersensitivity or intolerance to any component of the product.\n* Concomitant therapy with systemic immunomodulatory drugs (e.g., cyclosporine, apremilast), except methotrexate (MTX), the use of which will be compatible with the study.\n* Concomitant therapy with biologic agents such as anti-TNFα, anti-IL17, or anti-IL23.\n* Concomitant topical therapy with topical steroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations.\n* Pregnant or breastfeeding women",{"count":68,"type":22},21,[25],"The purpose of this interventional clinical study is to evaluate the safety and efficacy of PROXERA PSOMED 30, a topical medical device containing 30% urea, for the treatment of nail psoriasis in adults with nail psoriasis. The primary question the study aims to answer is whether PROXERA PSOMED 30 improves the clinical signs of nail psoriasis more effectively than a control treatment (Vaseline).\n\nResearchers will compare two similar target nails in the same participant, one treated with PROXERA PSOMED 30 and the other with Vaseline, to determine whether the active treatment leads to greater improvement in Nail Psoriasis Severity Index (NAPSI) scores over 24 weeks. The study will also evaluate local tolerability, patient satisfaction, and digital photographs of the treated nails.\n\nParticipants will be men or women between the ages of 18 and 65 with nail psoriasis for at least 6 months and a target NAPSI nail score of 3 or higher. A total of 21 participants is expected.\n\nParticipants will:\n\napply PROXERA PSOMED 30 to one target nail and petroleum jelly to the opposite target nail twice daily for 24 weeks; attend follow-up visits at baseline and after 4, 12, and 24 weeks; undergo nail assessments using the NAPSI score; have digital photographs of treated nails; report tolerability, satisfaction, and any adverse events during the study.",[72],"Nail Psoriasis",[72,74,75,35,36,37,39,76,77],"Psoriasis","PROXERA PSOMED 30","Nail Psoriasis Severity Index","Petrolatum","2026-04-15",{"date":49,"type":50},{"date":52,"type":22},{"date":82,"type":22},"2026-12-08",{"name":56,"class":57},""]